BD Syringe Certifications

Interlink® System and BD™
® ™
Cannulas
Interlink System and BD Cannulas BD SafetyGlide™ Syringes & Needles (sterile, single use) BD Eclipse™ Needles and Syringes BD PosiFlush™ Prefilled Syringes
A Global Leader in Hypodermic Products
BD™ Plastic Cannula Products for use with BD Blood Collection Assembly for use BD SafetyGlide™ Hypodermic Needle BD SafetyGlide™ Insulin Syringe BD Eclipse™ Needles BD Eclipse™ Needles with Syringes BD™ Prefilled Flush Syringes Are Available in a Wide Variety of Sizes
Baxter Interlink® System with Baxter Interlink®, Abbott LifeShield®, or 50 per box, 500 per case with Permanently Attached Needle 100 per box, 1,200 per case 50 per box, 300 per case and Solutions To Meet All Your Flush-Protocol Requirements.
100 per box, 1000 per case B. Braun SafeLine® Systems 305921 27 G x 5/8 in. Needle 100 per box, 400 per case 305757 30 G x 1/2 in.
303369 Threaded Lock Cannula 25 per box, 200 per case 305901 25 G x 5/8 in. Needle 305930 1 mL Insulin Syringe with 29 G x 1/2 in.
305758 27 G x 1/2 in. 1 mL BD Luer-Lok™ Syringe
305759 25 G x 5/8 in.
303380
BD Vacutainer® Specimen Collection Assembly 305916 25 G x 1 in. Needle 305932 1/2 mL Insulin Syringe with 29 G x 1/2 in. 305767 25 G x 1 1/2 in.
with Detachable Needle BD Ref. # Description NHRIC Number Box/Case
with BD™ Blunt Plastic Cannula 305902 23 G x 1 in. Needle 305935 3/10 mL Insulin Syringe with 29 G x 1/2 in. 305778 30 G x 1/2 in.
303370 Lever Lock Cannula
305761 25 G x 1 in.
305789 27 G x 1/2 in.
BD PosiFlush™ Normal Saline Syringes, all with 10 mL diameter
305900 22 G x 1 1/2 in. Needle 305934 1/2 mL Insulin Syringe with 30 G x 5/16 in. Thin Wall 305762 23 G x 1 in.
305937 3/10 mL Insulin Syringe with 31 G x 5/16 in. Thin Wall 305780 25 G x 5/8 in. 306544 3 mL 8290-306544 30/Box 480/Case
305915 21 G x 1 in. Thin Wall 305768 22 G x 1 in.
303365 Y Lock Cannula 306545 5 mL 8290-306545 30/Box 480/Case
305917 21 G x 1 1/2 in. Thin Wall 305763 22 G x 1 1/2 in.
305918 18 G x 1 1/2 in. Needle 305765 21 G x 1 1/2 in. Thin Wall 3 mL BD Luer-Lok™ Syringe 306546 10 mL 8290-306546 30/Box 480/Case
306547 10 mL Pump Compatible Syringe* 8290-306547 30/Box 480/Case
305764 21 G x 1 in. Thin Wall with Detachable Needle
305766 18 G x 1 1/2 in. 305769 23 G x 1 1/4 in. 306549 3 mL with Blunt Plastic Cannula 8290-306549 30/Box 120/Case
305781 25 G x 5/8 in. 306550 5 mL with Blunt Plastic Cannula 8290-306550 30/Box 120/Case
305787 25 G x 1 in. 306551 10 mL with Blunt Plastic Cannula 8290-306551 30/Box 120/Case
Syringes with BD™ Cannula for use with BD Cannula Products for use with 305782 23 G x 1 in. BD PosiFlush™ SF Saline Syringe
Baxter Interlink®, Abbott LifeShield®, 305788 22 G x 1 in.
Baxter Interlink®, Abbott LifeShield®, BD SafetyGlide™ Needle with Syringes BD SafetyGlide™ Tuberculin Syringe 305783 22 G x 1 1/2 in. 306553 10mL Sterile Field Syringe 8290-306553 30/Box 240/Case
or B. Braun SafeLine® Systems or B. Braun SafeLine® Systems with Permanently Attached Needle 305779 21 G x 1 in. BD PosiFlush™ SureScrub™ Saline Syringe
50 per box, 400 per case
100 per box, 800 per case 305784 21 G x 1 1/2 in. 306559 10mL with Alcohol Pad 8290-306559 30/Box 480 Case
100 per box, 1000 per case 100 per box, 400 per case
303391 3 mL Syringe with BD Twinpak™ Cannula
1 mL BD Luer Slip Syringe w/ Detachable Needle
303345 BD Blunt Plastic Cannula 305903 25 G x 5/8 in. 305945 1 mL Tuberculin Syringe with 27 G x 1/2 in. BD™ Pre-Filled Normal Saline Syringes
303346 3 mL Syringe with BD Blunt Plastic Cannula 5 mL BD Luer-Lok™ Syringe
303390 BD Twinpak™ Dual Cannula Device 305927 27 G x 5/8 in. Regular Bevel 306500 10 mL Fill in 10 mL Syringe 8290-306500 30/Box 120/Case
303401 3 mL Syringe with Vial Access Cannula
303367 Interlink® Vial Access Cannula 305946 1 mL Tuberculin Syringe with 26 G x 3/8 in. with Detachable Needle
306502 5 mL Fill in 10 mL Syringe 8290-306502 30/Box 120/Case
100 per box, 400 per case Intradermal Bevel 305785 22 G x 1 1/2 in.
3 mL BD Luer-Lok™ Syringe 306503 3 mL Fill in 10 mL Syringe 8290-306503 30/Box 120/Case
303347 5 mL Syringe with BD Blunt Plastic Cannula with Detachable Needle 306504 5 mL Fill in 5 mL Syringe 8290-306504 30/Box 120/Case
303348 10 mL Syringe with BD Blunt Plastic Cannula 305904 25 G x 5/8 in.
10 mL BD Luer-Lok™ Syringe
303392 5 mL Syringe with BD Twinpak™ Cannula 305924 25 G x 1 in. with Detachable Needle
305786 22 G x 1 1/2 in. 306507 3 mL Fill in 3 mL Syringe 8290-306507 30/Box 120/Case
303393 10 mL Syringe with BD Twinpak™ Cannula 305905 23 G x 1 in.
303403 5 mL Syringe with Interlink® Vial Access Cannula 305906 22 G x 1 1/2 in. 306508 2 mL Fill in 3 mL Syringe 8290-306508 30/Box 120/Case
303405 10 mL Syringe with Interlink® Vial Access Cannula 305909 21 G x 1 1/2 in. Thin Wall 306518 10 mL Fill in 10 mL Syringe with Blunt Plastic Cannula 8290-306518 30/Box 120/Case
306522 5 mL Fill in 5 mL Syringe with Blunt Plastic Cannula 8290-306522 30/Box 120/Case
5 mL BD Luer-Lok™ Syringe BD SafetyGlide™ Allergy Syringe Tray 306524 3 mL Fill in 3 mL Syringe with Blunt Plastic Cannula 8290-306524 30/Box 120/Case
with Detachable Needle with Permanently Attached Needle BD PosiFlush™ Heparin Lock Flush Syringes, 10 USP units/mL
25 per tray, 1000 per case
305950 1 mL Allergy Tray with 27 G x 1/2 in.
BD Safety-Lok™ Syringes (sterile, single use)

Regular Bevel
with Detachable Needle 305951 1 mL Allergy Tray with 26 G x 3/8 in. 306512 3 mL Fill in 3 mL Syringe 8290-306512 30/Box 120/Case
305908 22 G x 1 1/2 in. Intradermal Bevel 306525 5 mL Fill in 10 mL Syringe with Blunt Plastic Cannula 8290-306525 30/Box 120/Case
1 mL BD Safety-Lok™ Insulin Syringe

with Permanently Attached Needle
5 mL BD Safety-Lok™ Syringe
with Detachable Needle
BD Integra™
Needles and
BD Integra™ Needles and Syringes
Syringes BD PosiFlush™ Heparin Lock Flush Syringes, 100 USP units/mL
306513
306514
5 mL Fill in 10 mL Syringe
8290-306513
8290-306514
30/Box 120/Case
30/Box 120/Case
329464 29 G x 1/2 in. U-100 BD Ultra-Fine
™
305561 21 G x 1 1/2 in. BD Integra™ 3 mL Syringe BD Integra™ Needles 306517 3 mL Fill in 3 mL Syringe 8290-306517 30/Box 120/Case
with Detachable Needle 306528 2 mL Fill in 3 mL Syringe 8290-306528 30/Box 120/Case
100 per box, 1,000 per case
1 mL BD Safety-Lok™ Tuberculin Syringe 100 per box, 400 per case
305310 25 G x 5/8 in. Retracting Needle
Hypodermic
with Permanently Attached Needle BD PosiFlush™ Heparin Lock Flush Syringes, 10 USP units/mL
305269 3 mL Syringe with 25 G x 5/8 in. Needle 305311 25 G x 1 in. Retracting Needle
305270 3 mL Syringe with 25 G x 1 in. Needle 305312 23 G x 1 in. Retracting Needle 306413 3 mL 8290-306413 30/Box 480/Case
100 per box, 500 per case 306414 5 mL 8290-306414 30/Box 480/Case
10 mL BD Safety-Lok™ Syringe 305271 3 mL Syringe with 23 G x 1 in. Needle 305313 22 G x 1 1/2 in. Retracting Needle
Product Catalog
305553 27 G x 1/2 in. 305272 3 mL Syringe with 22 G x 1 1/2 in. Needle 3052751 18 G x 1 1/2 in. Blunt Fill Needle BD PosiFlush™ Heparin Lock Flush Syringes, 100 USP units/mL
305554 25 G x 5/8 in. with Detachable Needle 305273 3 mL Syringe with 21 G x 1 in. Needle 3058331, 2 18 G x 1 1/2 in. Blunt Filter Needle 306423 3 mL 8290-306423 30/Box 480/Case
305274 3 mL Syringe with 21 G x 1 1/2 in. Needle
50 per box, 400 per case 1 – 18 G Blunt Fill and Blunt Filter Needles have a non-retracting needle 306424 5 mL 8290-306424 30/Box 480/Case
2 – Packaged 50 Box/500 Case
305564 21 G x 1 1/2 in.
All products do not contain natural rubber latex or preservatives. A Complete Line of
3 mL BD Safety-Lok™ Syringe *Catalog No. 306547 10mL BD PosiFlush Normal Saline Flush Syringe is generally
compatible for use with syringe pumps.
Medication Administration
and Safety-Engineered
100 per box, 800 per case BD Integra™ 3 mL Syringe Only
309592 25 G x 5/8 in. 309596 22 G x 1 in.
BD Safety-Lok™ Syringes only,
Products For
309594
309593
23 G x 1 in.
22 G x 1 1/2 in.
309595 21 G x 1 1/2 in. BD Luer-Lok™ Tip
309606 3 mL Syringe Only 100 box/800 case
305283 3 mL Syringe Only
Brands are the property of their respective owners.
1 Becton Drive
Franklin Lakes, NJ 07417
The Healthcare Industry
BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company. © 2015 BD
305558 5 mL Syringe Only 50 box/400 case www.bd.com
305559 10 mL Syringe Only 50 box/400 case Printed in. USA 6/15 MSS0158-1
2771 Bristol Circle
Oakville, Ontario L6H 6R5
BD
BD™ Insulin
™
Insulin Syringes
Syringes (sterile, single use) BD™ Tuberculin Syringes BD™ Syringes & Needles (sterile, single use) BD PrecisionGlide™ Needles (sterile, single use) BD™ Disposal Solutions
BD Patient Room Collectors
3/10 mL BD Lo-Dose Insulin Syringe
™
1 mL BD Insulin Syringe 1/2 mL BD Tuberculin Syringe 1 mL BD Tuberculin Syringe 10 mL BD Syringe/Needle Combination 20 mL BD Syringe Only BD™ Regular Bevel Needles BD™ Blunt Fill Needles
Available in multiple colors
Self-Contained Package. 100 per box, 500 per case
with Permanently Attached Needle with Permanently Attached Needle
100 per box, 500 per case 1/100 mL
with Detachable Needle, Slip Tip
BD Luer-Lok™ Tip
48 per box, 192 per case 1 mL 100 per box, 1,000 per case
Reorder Needle
Reorder Needle
30 G Recykleen™
Self-Contained Package. 100 per box, 500 per case 302830 BD Luer-Lok™ Tip 305053 BD Recykleen™ Pearl, 3 gal 10/Case
Number Size Description Number Size Description 305054 BD Recykleen™ Red, 3 gal. 10/Case
328438 31 G x 5/16 in. U-100 BD Ultra-Fine™ Short Needle 329410 28 G x 1/2 in. U-100 BD Micro-Fine™ IV (Orange) 305620 27 G x 1/2 in. Regular Bevel 309623 27 G x 1/2 in. 309640 22 G x 1 in. 302831 Slip Tip
329412 27 G x 5/8 in. U-100 BD Micro-Fine™ IV (Orange) 309625 26 G x 3/8 in. Intradermal Bevel 305106 30 G x 1/2 in. 305180 18 G x 1 1/2 in. Horizontal Entry
200 per box, 200 per case 309642 21 G x 1 in. 120 per box, 480 per case
328418 31 G x 5/16 in. U-100 BD Ultra-Fine™ Short Needle

309626
309624
25 G x 5/8 in.
21 G x 1 in.
309643
309644
21 G x 1 1/2 in.
20 G x 1 in. 300613 Eccentric Tip
305128
305109
30 G x 1 in.
27 G x 1/2 in.
305181 18 G x 1 in. 27 G 305422 Pearl, Nestable, 2 gal.
Side Entry
10/Case
309645 20 G x 1 1/2 in. 305183 20 G x 1 in. 305443 Red, Nestable, 5.4 qt. 20/Case
324704 29 G x 1/2 in. U-100 BD Ultra-Fine™ 305136 27 G x 1 1/4 in.
305211 18 G x 1 1/2 in. Filter (5 Micron) 305444 Pearl, Nestable, 5.4 qt. 20/Case
324705 27 G x 1/2 in. U-100 BD Ultra-Fine™
1 mL BD Tuberculin Syringe Only 301629 27 G x 1 1/2 in. 305425 Pearl, Nestable, 5.4 qt. 12/Case
Blister Package. 100 per box, 500 per case
305064 18 G x 1 1/2 in. BD™ Blunt Fill Needle 305110 26 G x 3/8 in.

Intradermal
Bevel
26 G
329424 28 G x 1/2 in. U-100 BD Micro-Fine™ IV (Orange) BD Luer-Lok Tip, Thin Wall
30 mL BD Syringe Only
™
329420 28 G x 1/2 in. U-100 BD Micro-Fine™ IV 309659 Slip Tip 305111 26 G x 1/2 in. BD™ Short Bevel Needles BD Pharmaceutical Waste Sharps Collectors
Single Unit Graduation 100 per box, 400 per case 1/5 mL BD Phlebotomy Collectors
305122 25 G x 5/8 in. 100 per box, 1,000 per case
309639 21 G x 1 1/2 in.
56 per box, 224 per case 1 mL
302832 BD Luer-Lok™ Tip
305124 25 G x 7/8 in. Reorder Needle 25 G 305487
305635
1.5 qt.
1.0 qt.
36/Case
60/Case
305058
305622
BD Recykleen™, 5.4 qt.
Counterbalanced door, 3 gal.
20/Case
10/Case
305125 25 G x 1 in. Number Size Description
™ 302833 Slip Tip  
305127 25 G x 1 1/2 in. 305159 22 G x 1 1/2 in.
305633
305634
Blue Plug Cap, 3 gal.
Blue Hinged Top, 9 gal.
12/Case
8/Case
BD™ Syringes & Needles (sterile, single use)
BD Multi-Use Nestable Collectors 305329 Slide Top, 9 gal. 8/Case
1 mL BD Insulin Syringe with Detachable Needle
305143
305145
23 G x 3/4 in.
23 G x 1 in.
305178
305179
20 G x 1 in.
20 G x 1 1/2 in.
24 G 305480 Clear Top, Hinge Cap with Petals, 14 qt. 20/Case
305028
305328
Hinge Top, 17 gal.
Slide Top, 19 gal.
5/Case
5/Case
305464 Clear Top, Hinge Cap w/ Needle Ports, 14 qt. 20/Case
329461 28 G x 1/2 in. U-100 BD Micro-Fine™ IV (Orange) 305120 23 G x 1 1/4 in. 305188 19 G x 1 in. Thin Wall
Blister Package. 100 per box, 800 per case - 2 unit scale 305456 Clear Top, Hinge Cap, 14 qt. 20/Case
Self-Contained Package. 100 per box, 500 per case 1 mL BD Syringe/Needle Combination, Slip Tip 3 mL BD Syringe/Needle Combination 60 mL BD Syringe Only 305155 22 G x 1 in.
305189 19 G x 1 1/2 in. Thin Wall 305646 Clear Top, Tethered Cap, 14 qt. 20/Case
329465 28 G x 1/2 in. U-100 BD Micro-Fine™ IV (Orange)

329651
329652
25 G x 5/8 in. U-100 (Orange/Blue)
26 G x 1/2 in. U-100 (Orange/Tan) 100 per box, 800 per case 1/100 mL BD Luer-Lok™ Tip 10 mL BD Syringe Only 40 per box, 160 per case 1 mL
305156
305165
22 G x 1 1/2 in.
21 G x 1 in.
305199 18 G x 1 1/2 in. 23 G 305457
305465
Clear Top, Hinge Cap, 6 gal. 12/Case
Clear Top, Hinge Cap with Petals, 6 gal. 12/Case
BD RCRA Hazardous Waste Collectors
328468 31 G x 5/16 in. U-100 BD Ultra-Fine™ Short Needle 329622 25 G x 1 in. U-100 (Orange/Blue) 100 per box, 800 per case 1/10 mL 100 per box, 400 per case 1/5 mL Non-DOT
309597 26 G x 5/8 in. Sub-Q 309654 Slip Tip 305167 21 G x 1 1/2 in. 305066 Hinge Top, 3 gal. 12/Case
200 per box, 200 per case 309582 25 G x 1 1/2 in. 309577 21 G x 1 1/2 in. 309604 BD Luer-Lok™ Tip 309653 BD Luer-Lok™ Tip 305129 21 G x 2 in. Types of needle walls BD Large and Extra Large Collectors 305067 Hinge Top, 5 gal. 5/Case
22 G
309581 25 G x 1 in. 309575 21 G x 1 in. 301604 Slip Tip 305068 BD Recykleen™ Clear Hinge Top, 9 gal. 8/Case
324703 29 G x 1/2 in. U-100 BD Ultra-Fine 309570 25 G x 5/8 in. 309579 20 G x 1 1/2 in. 60 per box, 240 per case 305175 20 G x 1 in.
309571 23 G x 1 in. 309578 20 G x 1 in.
305482 Eccentric Tip
300866 Eccentric Tip 305176 20 G x 1 1/2 in.
and bevels 305615
305616
Red,
Red,
Clear
Clear
Hinged Top, 9 gal.
Slide Top, 9 gal.
8/Case
8/Case
305069
305071
BD Recykleen™ Clear
Slide Top, 9 gal.
Hinge Top, 17 gal.
8/Case
5/Case
309574 22 G x 1 1/2 in. 309580 18 G x 1 1/2 in. 25 per box, 100 per case
1 mL BD Insulin Syringe Only 309573 22 G x 1 1/4 in. 305060 18 G x 1 1/2 in.
309695 BD Luer-Lok™ Tip Control Syringe
305186 19 G x 1 in. Thin Wall
The Thin Wall needle is thinner than a Regular
305601
305602
Red,
Red,
Clear
Clear
Hinged Top, Gasketed, 9 gal.
Slide Top, Gasketed, 9 gal.
8/Case
8/Case
305072 BD Recykleen™ Clear Slide Top, 19 gal. 5/Case
309572 22 G x 1 in. Blunt Fill Needle
Blister Package. 200 per box, 1600 per case- 2 unit scale
329654 U-100 Slip Tip (Orange)
1 mL BD Luer-Lok ™
Syringe/Needle Combination 309569 22 G x 3/4 in.
305187
305195
19 G x 1 1/2 in.
18 G x 1 in.
Thin Wall Wall needle. The inner diameter is bigger without
any increase in the outside diameter. For example,
21 G 305610
305665
Red,
Red,
Clear
Clear
Hinged Top, 17 gal.
5/Case
5/Case BD Disposal Solutions Cabinets and Accessories
100 per box, 800 per case 1/100 mL 305196 18 G x 1 1/2 in. a 21 G Thin Wall needle has the same outside 305609 Red, Clear Slide Top, 19 gal. 5/Case
305462 Lab Syringe Eccentric Tip Non-Sterile, 305096 BD Recykleen™ Brown Cabinet, 5.4 qt. 1/Case
diameter as a 21 G Regular Wall, but has the 305666 Red, Clear Slide Top, Gasketed, 19 gal. 5/Case
Clean, Ready-to-use Bulk-Pak 305197 16 G x 1 in. 305098 BD Recykleen™ Green Cabinet, 5.4 qt. 1/Case
309637 20 G x 1 in.
60 mL BD Catheter Tip Syringe Only 305198 16 G x 1 1/2 in.
same inner diameter as a 20 G needle. Thin Wall
allows the same flow volume as a Regular Wall 20 G BD Chemotherapy Collectors
305097 BD Recykleen™ Brown Cabinet, 2 and 3 gal. 1/Case
NOTE: All of the syringes in this section are in an Easy-Peel Blister
Package unless otherwise noted as Self-Contained Package.
100 per box, 800 per case - 1 unit scale
309629 BD Luer-Lok™, 1 mL
3 mL BD Syringe Only (with Tip Shield) 305115 26 G x 5/8 in. Sub-Q needle one gauge larger. Thin Wall is available in
18, 19, 21, 22, and 23 gauge sizes.
305099
305017
BD Recykleen™ Green Cabinet, 2 and 3 gal. 1/Case
Locking Wall Cabinet, 5.4 qt. 1/Case
305193 23 G x 1 in. Thin Wall IM 305493 Yellow, Plug Cap, 5 gal. 8/Case 305420 Locking Wall Cabinet, 2 and 3 gal. 1/Case
200 per box, 800 per case 1/10 mL 40 per box, 160 per case 1 mL 305578 Yellow, Screw Cap, 5 gal. 8/Case 305475 Nestable, Vertical Entry Wall Cabinet, 3.2 qt. 12/Case
305194 23 G x 1 1/2 in. Thin Wall IM 305603 Yellow, Clear Hinged Top, 9 gal. 8/Case
BD Allergy Syringes
™
™ 1 mL BD Luer-Lok ™
Syringe Only
309657
309656
BD Luer-Lok™ Tip
Slip Tip
309620 Catheter Tip
305185 18 G x 1 1/2 in. Thin Wall Fill
Regular Wall
19 G 305604
305613
Yellow,
Yellow,
Clear Slide Top, 9 gal.
8/Case
5/Case
305409
305447
305451
Locking Wall Bracket, 2 and 3 gal.
Locking Wall Bracket, 5.4 qt. Collectors
One-Piece, Cup Bracket, 1.4 qt.
10/Case
10/Case
12/Case
305177 21 G x 1 in. Thin Wall IV 305614 Yellow, Clear Hinged Top, 17 gal. 5/Case
100 per box, 800 per case 1/100 mL 305485 Nestable, Bracket, 8 qt., 14 qt. and 6 gal. 12/Case
305190 21 G x 1 1/2 in. Thin Wall IV 305494 Security Lock 12/Case
BD Multi-Use One-Piece Collectors
18 G
309628 BD Luer-Lok™ 305496 One-Piece, Bracket, 6.9 qt. and 8.2 qt. 12/Case
BD SafetyGlide Allergy Syringe Tray
™
1/2 mL BD Allergist Tray with 5 mL BD Syringe/Needle Combination 305488 Small, 3.3 qt. 24/Case
305497
305552
One-Piece, Strap, 3.3 qt. through 5 gal.
Stabilizer, 2 and 3 gal.
12/Case
5/Case
with Permanently Attached Needle BD Luer-Lok™ Tip Thin Wall 305570 Nestable, Stabilizer, 8 qt. 5/Case
Permanently Attached Needle BD Pharmacy Convenience Paks 305489 Medium, 6.9 qt. 12/Case
25 per tray, 1,000 per case 25 syringes per tray, 1,000 per case 100 per box, 400 per case 1/5 mL Types of syringe tips 305490 Large, 8.2 qt. 12/Case 305588
305021
Wall/Cart, 2 and 3 gal.
Stabilizer, 5.4 qt. 5/Case
6/Case
16 G
Tray Contents: 305491 Open Top, 5 gal. 8/Case
305950 1 mL Allergy Tray with 309630 22 G x 1 in. 309634 20 G x 1 in. 305477 Large Funnel, 5 gal. 8/Case 305494 Padlock 12/Case
305951
27 G x 1/2 in. Regular Bevel
1 mL Allergy Tray with
305535
305536
27 G x 3/8 in. Intradermal Bevel 3 mL BD Syringe/Needle Combination 309631
309632
22 G x 1 1/2 in.
21 G x 1 in.
309635
305062
20 G x 1 1/2 in.
18 G x 1 1/2 in. Blunt Fill Needle
309701
309702
1 mL Luer Slip Tip
3 mL BD Luer-Lok™ Tip
25 syringes only per sterile tray, 12 trays per case of 300
BD Luer-Lok™
Tip Sizes:
1 mL
Slip Tip Sizes:
1 mL
3 mL
305577
305557
Screw Cap, 5 gal.
Regular Funnel, 1.4 qt.
8/Case
36/Case
305495
305970
XL Security Bracket, 5 gal. 12/Case
Cup Bracket, 1 qt. 12/Case
26 G x 3/8 in. Intradermal Bevel
BD Luer-Lok™ Tip, Thin Wall 309633 21 G x 1 1/2 in. 309703 5 mL BD Luer-Lok™ Tip 25 syringes only per sterile tray, 12 trays per case of 300 3 mL 5 mL BD
100 per box, 800 per case 1/10 mL 309605 10 mLBD Luer-Lok™ Tip 20 syringes only per sterile tray, 12 trays per case of 240 5 mL 10 mL Regular Short Intradermal Conventional See BD Disposal Solutions Catalog for a complete
10 mL 20 mL
305617 20 mLBD Luer-Lok™ Tip 10 each Syringes only per sterile tray, 12 trays per case of 120 20 mL 30 mL Bevel Bevel Bevel Needle & listing of products available.
309587 26 G x 5/8 in. Sub-Q
305618 30 mLBD Luer-Lok™ Tip 10 each Syringes only per sterile tray, 12 trays per case of 120 30 mL 60 mL
Syringe
309588 23 G x 1 in. IM
1 mL BD Allergist Tray with 1 mL BD Allergy Syringe with 309589 23 G x 1 1/2 in. IM 309680 60 mLBD Luer-Lok™ Tip 20 each Syringes only per sterile tray, 6 trays per case of 120
60 mL
Color Chart
Permanently Attached Needle Permanently Attached Needle 309598 21 G x 1 in. IV
25 syringes per tray, 1,000 per case 100 per box, 500 per case
309599 21 G x 1 1/2 in. IV 5 mL BD Syringe Only BD Luer Slip™
BD Luer-Lok™ Sterile Syringe Tip Cap Sterile Syringe Tip Cap Tray
305537 26 G x 1/2 in. Regular Bevel 305500 28 G x 1/2 in. Regular Bevel
305538 26 G x 1/2 in. Intradermal Bevel 309646 BD Luer-Lok™ Tip 200 per box, 2000 per case Eccentric Catheter Tip
50 per tray, 1,000 per box, Tip Sizes: Sizes:
305539 26 G x 3/8 in. Intradermal Bevel 309647 Slip Tip 305819 BD Syringe Tip Cap 10 mL 2 oz. only
305540 27 G x 1/2 in. Regular Bevel 4,000 per case 20 mL
305541 27 G x 3/8 in. Intradermal Bevel 305822 Syringe Tip Cap Tray 60 mL
305542 27 G x 3/8 in. Regular Bevel
BD
BD™ Insulin
™
Insulin Syringes
™
BD Luer-Lok™ Tip
Reorder Needle
Reorder Needle
30 G Recykleen™

309626
309624
25 G x 5/8 in.
21 G x 1 in.
309643
309644
21 G x 1 1/2 in.
305128
305109
30 G x 1 in.
27 G x 1/2 in.
Side Entry
10/Case

Intradermal
Bevel
26 G
™
309639 21 G x 1 1/2 in.
305635
1.5 qt.
1.0 qt.
36/Case
60/Case
305058
305622
20/Case
10/Case
™ 302833 Slip Tip  
305127 25 G x 1 1/2 in. 305159 22 G x 1 1/2 in.
305633
305634
12/Case
8/Case
305143
305145
23 G x 3/4 in.
23 G x 1 in.
305178
305179
20 G x 1 in.
20 G x 1 1/2 in.
305028
305328
Hinge Top, 17 gal.
Slide Top, 19 gal.
5/Case
5/Case

329651
329652
305156
305165
22 G x 1 1/2 in.
21 G x 1 in.
305199 18 G x 1 1/2 in. 23 G 305457
305465
22 G
309571 23 G x 1 in. 309578 20 G x 1 in.
and bevels 305615
305616
Red,
Red,
Clear
Clear
Hinged Top, 9 gal.
Slide Top, 9 gal.
8/Case
8/Case
305069
305071
Slide Top, 9 gal.
Hinge Top, 17 gal.
8/Case
5/Case
305601
305602
Red,
Red,
Clear
Clear
8/Case
8/Case
305187
305195
19 G x 1 1/2 in.
18 G x 1 in.
21 G 305610
305665
Red,
Red,
Clear
Clear
Hinged Top, 17 gal.
5/Case
309637 20 G x 1 in.
18, 19, 21, 22, and 23 gauge sizes.
305099
305017
BD Allergy Syringes
™
Syringe Only
309657
309656
BD Luer-Lok™ Tip
Slip Tip
309620 Catheter Tip
Regular Wall
19 G 305604
305613
Yellow,
Yellow,
8/Case
5/Case
305409
305447
305451
10/Case
10/Case
12/Case
18 G
™
305497
305552
12/Case
5/Case
305021
6/Case
16 G
305951
305535
305536
309632
22 G x 1 1/2 in.
21 G x 1 in.
309635
305062
20 G x 1 1/2 in.
309701
309702
1 mL Luer Slip Tip
BD Luer-Lok™
Tip Sizes:
1 mL
Slip Tip Sizes:
1 mL
3 mL
305577
305557
Screw Cap, 5 gal.
8/Case
36/Case
305495
305970
10 mL 20 mL
309587 26 G x 5/8 in. Sub-Q
Syringe
309588 23 G x 1 in. IM
60 mL
Color Chart
BD
BD™ Insulin
™
Insulin Syringes
™
BD Luer-Lok™ Tip
Reorder Needle
Reorder Needle
30 G Recykleen™

309626
309624
25 G x 5/8 in.
21 G x 1 in.
309643
309644
21 G x 1 1/2 in.
305128
305109
30 G x 1 in.
27 G x 1/2 in.
Side Entry
10/Case

Intradermal
Bevel
26 G
™
309639 21 G x 1 1/2 in.
305635
1.5 qt.
1.0 qt.
36/Case
60/Case
305058
305622
20/Case
10/Case
™ 302833 Slip Tip  
305127 25 G x 1 1/2 in. 305159 22 G x 1 1/2 in.
305633
305634
12/Case
8/Case
305143
305145
23 G x 3/4 in.
23 G x 1 in.
305178
305179
20 G x 1 in.
20 G x 1 1/2 in.
305028
305328
Hinge Top, 17 gal.
Slide Top, 19 gal.
5/Case
5/Case

329651
329652
305156
305165
22 G x 1 1/2 in.
21 G x 1 in.
305199 18 G x 1 1/2 in. 23 G 305457
305465
22 G
309571 23 G x 1 in. 309578 20 G x 1 in.
and bevels 305615
305616
Red,
Red,
Clear
Clear
Hinged Top, 9 gal.
Slide Top, 9 gal.
8/Case
8/Case
305069
305071
Slide Top, 9 gal.
Hinge Top, 17 gal.
8/Case
5/Case
305601
305602
Red,
Red,
Clear
Clear
8/Case
8/Case
305187
305195
19 G x 1 1/2 in.
18 G x 1 in.
21 G 305610
305665
Red,
Red,
Clear
Clear
Hinged Top, 17 gal.
5/Case
309637 20 G x 1 in.
18, 19, 21, 22, and 23 gauge sizes.
305099
305017
BD Allergy Syringes
™
Syringe Only
309657
309656
BD Luer-Lok™ Tip
Slip Tip
309620 Catheter Tip
Regular Wall
19 G 305604
305613
Yellow,
Yellow,
8/Case
5/Case
305409
305447
305451
10/Case
10/Case
12/Case
18 G
™
305497
305552
12/Case
5/Case
305021
6/Case
16 G
305951
305535
305536
309632
22 G x 1 1/2 in.
21 G x 1 in.
309635
305062
20 G x 1 1/2 in.
309701
309702
1 mL Luer Slip Tip
BD Luer-Lok™
Tip Sizes:
1 mL
Slip Tip Sizes:
1 mL
3 mL
305577
305557
Screw Cap, 5 gal.
8/Case
36/Case
305495
305970
10 mL 20 mL
309587 26 G x 5/8 in. Sub-Q
Syringe
309588 23 G x 1 in. IM
60 mL
Color Chart
BD
BD™ Insulin
™
Insulin Syringes
™
BD Luer-Lok™ Tip
Reorder Needle
Reorder Needle
30 G Recykleen™

309626
309624
25 G x 5/8 in.
21 G x 1 in.
309643
309644
21 G x 1 1/2 in.
305128
305109
30 G x 1 in.
27 G x 1/2 in.
Side Entry
10/Case

Intradermal
Bevel
26 G
™
309639 21 G x 1 1/2 in.
305635
1.5 qt.
1.0 qt.
36/Case
60/Case
305058
305622
20/Case
10/Case
™ 302833 Slip Tip  
305127 25 G x 1 1/2 in. 305159 22 G x 1 1/2 in.
305633
305634
12/Case
8/Case
305143
305145
23 G x 3/4 in.
23 G x 1 in.
305178
305179
20 G x 1 in.
20 G x 1 1/2 in.
305028
305328
Hinge Top, 17 gal.
Slide Top, 19 gal.
5/Case
5/Case

329651
329652
305156
305165
22 G x 1 1/2 in.
21 G x 1 in.
305199 18 G x 1 1/2 in. 23 G 305457
305465
22 G
309571 23 G x 1 in. 309578 20 G x 1 in.
and bevels 305615
305616
Red,
Red,
Clear
Clear
Hinged Top, 9 gal.
Slide Top, 9 gal.
8/Case
8/Case
305069
305071
Slide Top, 9 gal.
Hinge Top, 17 gal.
8/Case
5/Case
305601
305602
Red,
Red,
Clear
Clear
8/Case
8/Case
305187
305195
19 G x 1 1/2 in.
18 G x 1 in.
21 G 305610
305665
Red,
Red,
Clear
Clear
Hinged Top, 17 gal.
5/Case
309637 20 G x 1 in.
18, 19, 21, 22, and 23 gauge sizes.
305099
305017
BD Allergy Syringes
™
Syringe Only
309657
309656
BD Luer-Lok™ Tip
Slip Tip
309620 Catheter Tip
Regular Wall
19 G 305604
305613
Yellow,
Yellow,
8/Case
5/Case
305409
305447
305451
10/Case
10/Case
12/Case
18 G
™
305497
305552
12/Case
5/Case
305021
6/Case
16 G
305951
305535
305536
309632
22 G x 1 1/2 in.
21 G x 1 in.
309635
305062
20 G x 1 1/2 in.
309701
309702
1 mL Luer Slip Tip
BD Luer-Lok™
Tip Sizes:
1 mL
Slip Tip Sizes:
1 mL
3 mL
305577
305557
Screw Cap, 5 gal.
8/Case
36/Case
305495
305970
10 mL 20 mL
309587 26 G x 5/8 in. Sub-Q
Syringe
309588 23 G x 1 in. IM
60 mL
Color Chart
BD
BD™ Insulin
™
Insulin Syringes
™
BD Luer-Lok™ Tip
Reorder Needle
Reorder Needle
30 G Recykleen™

309626
309624
25 G x 5/8 in.
21 G x 1 in.
309643
309644
21 G x 1 1/2 in.
305128
305109
30 G x 1 in.
27 G x 1/2 in.
Side Entry
10/Case

Intradermal
Bevel
26 G
™
309639 21 G x 1 1/2 in.
305635
1.5 qt.
1.0 qt.
36/Case
60/Case
305058
305622
20/Case
10/Case
™ 302833 Slip Tip  
305127 25 G x 1 1/2 in. 305159 22 G x 1 1/2 in.
305633
305634
12/Case
8/Case
305143
305145
23 G x 3/4 in.
23 G x 1 in.
305178
305179
20 G x 1 in.
20 G x 1 1/2 in.
305028
305328
Hinge Top, 17 gal.
Slide Top, 19 gal.
5/Case
5/Case

329651
329652
305156
305165
22 G x 1 1/2 in.
21 G x 1 in.
305199 18 G x 1 1/2 in. 23 G 305457
305465
22 G
309571 23 G x 1 in. 309578 20 G x 1 in.
and bevels 305615
305616
Red,
Red,
Clear
Clear
Hinged Top, 9 gal.
Slide Top, 9 gal.
8/Case
8/Case
305069
305071
Slide Top, 9 gal.
Hinge Top, 17 gal.
8/Case
5/Case
305601
305602
Red,
Red,
Clear
Clear
8/Case
8/Case
305187
305195
19 G x 1 1/2 in.
18 G x 1 in.
21 G 305610
305665
Red,
Red,
Clear
Clear
Hinged Top, 17 gal.
5/Case
309637 20 G x 1 in.
18, 19, 21, 22, and 23 gauge sizes.
305099
305017
BD Allergy Syringes
™
Syringe Only
309657
309656
BD Luer-Lok™ Tip
Slip Tip
309620 Catheter Tip
Regular Wall
19 G 305604
305613
Yellow,
Yellow,
8/Case
5/Case
305409
305447
305451
10/Case
10/Case
12/Case
18 G
™
305497
305552
12/Case
5/Case
305021
6/Case
16 G
305951
305535
305536
309632
22 G x 1 1/2 in.
21 G x 1 in.
309635
305062
20 G x 1 1/2 in.
309701
309702
1 mL Luer Slip Tip
BD Luer-Lok™
Tip Sizes:
1 mL
Slip Tip Sizes:
1 mL
3 mL
305577
305557
Screw Cap, 5 gal.
8/Case
36/Case
305495
305970
10 mL 20 mL
309587 26 G x 5/8 in. Sub-Q
Syringe
309588 23 G x 1 in. IM
60 mL
Color Chart
® ™
Cannulas
305759 25 G x 5/8 in.
303380
305761 25 G x 1 in.
305789 27 G x 1/2 in.

Regular Bevel

BD Integra™
Needles and
306513
306514
8290-306513
8290-306514
30/Box 120/Case
30/Box 120/Case
™
Hypodermic
Product Catalog
305564 21 G x 1 1/2 in.
309592 25 G x 5/8 in. 309596 22 G x 1 in.
Products For
309594
309593
23 G x 1 in.
22 G x 1 1/2 in.
1 Becton Drive
2771 Bristol Circle
® ™
Cannulas
305759 25 G x 5/8 in.
303380
305761 25 G x 1 in.
305789 27 G x 1/2 in.

Regular Bevel

BD Integra™
Needles and
306513
306514
8290-306513
8290-306514
30/Box 120/Case
30/Box 120/Case
™
Hypodermic
Product Catalog
305564 21 G x 1 1/2 in.
309592 25 G x 5/8 in. 309596 22 G x 1 in.
Products For
309594
309593
23 G x 1 in.
22 G x 1 1/2 in.
1 Becton Drive
2771 Bristol Circle
® ™
Cannulas
305759 25 G x 5/8 in.
303380
305761 25 G x 1 in.
305789 27 G x 1/2 in.

Regular Bevel

BD Integra™
Needles and
306513
306514
8290-306513
8290-306514
30/Box 120/Case
30/Box 120/Case
™
Hypodermic
Product Catalog
305564 21 G x 1 1/2 in.
309592 25 G x 5/8 in. 309596 22 G x 1 in.
Products For
309594
309593
23 G x 1 in.
22 G x 1 1/2 in.
1 Becton Drive
2771 Bristol Circle
® ™
Cannulas
305759 25 G x 5/8 in.
303380
305761 25 G x 1 in.
305789 27 G x 1/2 in.

Regular Bevel

BD Integra™
Needles and
306513
306514
8290-306513
8290-306514
30/Box 120/Case
30/Box 120/Case
™
Hypodermic
Product Catalog
305564 21 G x 1 1/2 in.
309592 25 G x 5/8 in. 309596 22 G x 1 in.
Products For
309594
309593
23 G x 1 in.
22 G x 1 1/2 in.
1 Becton Drive
2771 Bristol Circle
October 21, 2019
Becton Dickinson and Company
Meriam Youssef
Senior Manager Regulatory Affairs
1 Becton Drive
Franklin Lakes, New Jersey 07417
Re: K190054
Trade/Device Name: BD Ultra-Fine™ Syringe
Regulation Number: 21 CFR 880.5860
Regulation Name: Piston Syringe
Regulatory Class: Class II
Product Code: FMF
Dated: September 19, 2019
Received: September 23, 2019
Dear Meriam Youssef:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.08
Silver Spring, MD 20993
www.fda.gov
K190054 - Becton Dickinson and Company Page 2
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rumi
Rumi Young -S
c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
cn=Rumi Young -S,
Young -S
For CAPT Alan M.
Assistant Director
0.9.2342.19200300.100.1.1=20024
Stevens67913
2019.10.21 13:36:29 -04'00'
DHT3C: Division of Drug Delivery and

General Hospital Devices,
and Human Factors
OHT3: Office of Gastrorenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2021
See PRA Statement below.
K190054 510(k) Summary
Submitted By: Meriam Youssef

Sr. Manager Regulatory Affairs, BD Medical- Diabetes Care
1 Becton Drive
Date Prepared: September 19, 2019
Device Name: Trade Name: BD Insulin Syringe™

Common Name: Syringe, Piston
Regulation Name: Piston syringe
Regulation: 21 CFR 880.5860
Product Code: FMF
Legally marketed predicate device to which substantial equivalence is being claimed:

• BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Hypodermic Syringe, BD Tuberculin Syringes with the
BD Ultra-Fine™ needle and BD Tuberculin Syringes with Micro-Fine™ IV Needle (K170386)
Device Description:
The subject BD Tuberculin Syringes are a plastic syringe designed for subcutaneous injection of a desired dose of U 100
insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. The BD Insulin
Syringes are sterile, single use, and non-pyrogenic. These devices operate on the principles of a piston syringe. The BD
Insulin Syringe with 6mm length cannula have a sub-brand name of BD Veo™ Insulin Syringe.
The BD Syringes are offered in the following sizes:
Syringe size (mL) Bevel Cannula length (mm) Gauge (G)
0.3mL 3 12.7mm 29G
0.3mL 3 12.7mm 30G
0.3mL 3 8mm 29G
0.3mL 3 8mm 31G
0.3mL 3 6mm 31G
0.5mL 3 12.7mm 28G
0.5mL 3 12.7mm 29G
0.5mL 3 12.7mm 30G
0.5mL 3 8mm 31G
0.5mL 3 6mm 31G
1mL 3 16mm 27G
1mL 3 12.7mm 28G
1mL 3 12.7mm 29G
1mL 3 12.7mm 30G
1mL 3 8mm 30G
1mL 3 8mm 31G
1mL 3 6mm 31G
1mL 3 16mm 27G
Indications for Use:
Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins.
Differences in Indications for use: The indications for use are the same as the predicate.
Substantial Equivalence Discussion:

Predicate Device Comparison
BD Ultra-Fine™ Insulin
Syringe, BD Ultra-Fine™
General Information Subject Device: II Insulin Syringe, BD
Feature Insulin Syringes with the
BD Insulin Syringe
BD Ultra-Fine™ needle
and BD Insulin Syringes
with Micro-Fine™ IV
Needle
510(k) Number K190054 K170386 N/A
Device Classification Syringe Piston Same Same
Regulation Number 880.586 Same Same
Product Code FMF Same Same
Becton Dickinson insulin Becton Dickinson insulin
syringes are intended for syringes are intended for
Indications of Use Same
subcutaneous injection of subcutaneous injection of
U 100 insulins U-100 insulins.
Specific Drug Use U-100 Insulin Same Same
1mL, The subject device
includes a 0.5mL and
Capacity 0.5mL, 1mL
0.3ml model.
0.3mL
Dimensional
modifications to
Bevel 3 3
primary bevel of
cannula
Cannula Gauge Size(s) 27G, 28G, 29G, 30G, 31G 27G, 28G, 29G, 30G, 31G Same
Snap fit needle hub for
0.3mL and 0.5mL designs
Introduction of one glue
for permanently Integral barrel for 1mL
well design for 1mL
attached needles design for
Nozzle Tip Type barrel configuration
permanently attached
Integral barrel for 1mL
needles
design for
permanently attached
needles
1 unit increments and ½ Addition of ½ unit scale
unit increments (0.3mL) 2 units increments mark increments
Scale Markings
1 unit increments (0.5mL) (1mL)
2 units increments (1mL)
Predicate Device Comparison
BD Ultra-Fine™ Insulin
Syringe, BD Ultra-Fine™
General Information Subject Device: II Insulin Syringe, BD
Feature Insulin Syringes with the
BD Insulin Syringe
BD Ultra-Fine™ needle
and BD Insulin Syringes
with Micro-Fine™ IV
Needle
Addition of retention
Polybag for self-contained Polybag for self-contained ring to 1mL
syringe and blister pack syringe and blister pack self-contained insulin
Packaging Configuration syringe
(multiple blister packs per (individual blister pack)
perforated sheet) offerings offerings Multiple blister packs
per perforated sheet
6mm, 8mm, 12.7mm, 6mm, 8mm, 12.7mm,
Cannula Length Size(s) Same
16mm 16mm
Cannula (Needle) material 304 Stainless Steel 304 Stainless Steel Same
Cannula (Needle) shield Polyethylene Polyethylene Modification to the co-
material and Cap (for monomer of
plunger rod) material polyethylene material
Cannula cover color Orange Orange Same
Modification to
Lubricant Medical Grade Silicone Medical Grade Silicone lubricant formulation
carrier solvent
Cannula bonding New 0.3mL & 0.5mL
UV Cured Adhesive UV Cured Adhesive UV Cured Adhesive
adhesive (UV cured)
Solvent based Markem Solvent based Markem Same
Scale marking ink
black colored ink black colored ink
Remove colorant
Plunger rod material Polystyrene Polystyrene additive from the
plunger rod component
Plunger tip (stopper) Same
Rubber stopper Rubber stopper
material
Polypropylene Polypropylene New material

Barrel and Hub Material formulation of
polypropylene
Single Use Only YES YES Same
Non-Pyrogenic YES YES Same
Sterile (10-6) YES YES Same
Discussion:
Apart from the above mentioned modifications to the design and materials, there are no technological differences
between the subject and the predicate devices. The design modifications were assessed through performance testing
per ISO 8537 and ISO 9626. The material changes were evaluated per ISO 10993-1.
The differences between the predicate and the subject device do not raise any new or different questions of safety or
effectiveness.
Non-Clinical Testing:
Following BD’s Quality System processes, required testing was conducted to validate the cumulative modifications
made to the subject devices.
Substantial Equivalence is being supported with full performance testing representing the current BD Insulin Syringe
devices currently marketed.
Bench functional performance
• Testing was conducted according to ISO 8537:2016 Sterile single-use syringes, with or without needle,
for insulin, and ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
This testing included Air Leakage, Cannula Pull Force, Cap Pull Force, Hub Pull Force, Liquid Leakage,
Needle Break-Off Force, Penetration Force, Scale Print Permanency, Shield Pull Force, Syringe Filling
Force, Syringe Injection Force (Force to Expel Water), Volumetric Accuracy, Dead Space and Corrosion
Resistance.
Biocompatibility testing
• Testing was conducted according to relevant sections of ISO 10993:2019 Biological evaluation of
medical devices. This testing included Cytotoxicity, Sensitization (GP Max), Sensitization,
Intracutaneous Reactivity, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity,
Subacute/Subchronic Toxicity, Hemocompatibility, and Genotoxicity (Bacterial and Mammalian). The
medical device is classified as: externally communicating, blood path indirect, with prolonged contact
duration.
Additional Testing:
ASTM F2148: 2013 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine
Local Lymph Node Assay (LLNA), ISO 11137-1:2006/Amd 2013(E) Sterilization of health care
products — Radiation — Part 1: Requirements for development, validation and routine control of a
sterilization process for medical devices, ISO 11137-2:2013(E) Sterilization of health care products —
Radiation — Part 2: Establishing the sterilization dose, ISO 11137-3: 2017(E) Sterilization of health
care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and
routine control, and ISO 11737-1:2018(E) Sterilization of health care products — Microbiological
methods — Part 1: Determination of a population of microorganisms on products .
Results of testing demonstrated the BD Insulin Syringes met requirements for its intended use and is as safe and
effective as its predicate device.
Clinical Testing:
Not Applicable
Conclusion:
The modifications to the design, dimensions, and materials of the subject device met the requirements of the standards.
The differences between the predicate and the subject device do not raise any new or different questions of safety or
effectiveness.
The BD Insulin Syringes are substantially equivalent to the BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II
Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™
IV Needle cleared under K170386 with respect to the indications for use, target populations, treatment method, use
environment and technological characteristics.
Donore Road,
Drogheda,
Co. Louth,
Ireland.
t: +353.(0)419871500
f: +353.(0)419839066
DECLARATION OF CONFORMITY bd.com
Legal Manufacturer: Becton, Dickinson and Company Limited,

Donore Road,
Drogheda,
Co. Louth, Ireland.
Authorised Representative: NA
Manufacturing Site: Manufactured on behalf of Becton, Dickinson and Company, Limited by:
Becton Dickinson S.A.

Crta. Mequinenza s/n.
22520 – Fraga
HUESCA – SPAIN
Products: BD MicrolanceTM 3 Needles (see attached list for the different types)
Classification: Class IIa, Rule 6
Conformity Assessment Route: Annex VII and Annex V
GMDN: 59230
We herewith declare that for the above mentioned products their product design meets the provisions of the European
Medical Device Directive 93/42/EEC of 14 June 1993 concerning medical devices. All supporting documentation is
retained at the premises of the manufacturer or subcontractor.
Harmonized standards: EN 556-1:2001/AC:2006, EN 1041:2008, EN1707:1996, EN 20594-1:1993/AC:1996,
EN IS0 10993-1:2009/AC:2010, EN IS0 10993-3:2014, EN IS0 10993-4:2009, EN IS0
10993-5:2009, EN IS0 10993-7:2008/AC2009, EN IS0 10993-11:2009, EN IS0 10993-
12:2012, EN ISO 10993-13:2010, EN ISO 10993-15:2009, EN IS0 10993-17:2009; EN
IS0 10993-18:2009; EN ISO 11135-1:2007, EN ISO 11138-2:2009, EN ISO 11737-
1:2006/AC:2009, EN ISO 11737-2:2009, EN ISO 11607-1:2009, EN ISO 11607-
2:2006, EN ISO 13485:2016/AC:2016, EN 14155:2011/ AC:2011, EN ISO
14971:2012, EN ISO15223-1:2016,
Non -Harmonised Standards ISO 14644-1:1999, EN IS0 10993-2:2006, IS0 10993-10:2009, ISO 9626: 1995, ISO
2859-1:1999, ISO 7864:2016, ISO 594-1:1993, ISO 594-2:1998; ISO 6009; 1995/COR
2008
Notified Body: NSAI
1 Swift Square, Northwood, Santry
Dublin 9, Ireland
Telephone: 353-1-807-3800
Number of Notified Body: 0050
CE Certificate number: 252.157
Date of issue of original CE certificate: 24 July 2012
Date: 04 November 2019
Name Andrew Roche

Function QA/RA
BD Microlance 3 Revision Number: 09

The content of this document cannot be reproduced or distributed outside the Company without the authorization of BD
Page 1 of 3
Directors: C. Reynolds, P. Keenan, D. Hopkin (UK)

Secretary: P. Keenan
Registered in Ireland (Registration Number 19996).

Donore Road,
Drogheda,
Co. Louth,
Ireland.
t: +353.(0)419871500
f: +353.(0)419839066
BD Microlance TM 3 Needles
STERILE NEEDLES
PRODUCT DESCRIPTION
CATALOG No. (Imperial, inch) (S.I.) mm
300094 22G x 2 0.7 x 50
300300 26G x 3/8 0.45 x 10
300400 25G x 1 0.5 x 25
300600 25G x 5/8 0.5 x 16
300635 27G x ½ 0.4 x 13
300637 16G x 1½ 1.6 x 40
301155 21G x 2 0.8 x 50
301500 19G x 1½ 1.1 x 40
301700 19G x 1 1.1 x 25
301750 19G x 2 1.1 x 50
301900 18G x 2 1.2 x 50
302200 27G x ¾ 0.4 x 19
303800 26G x ½ 0.45 x 13
304000 30G x ½ 0.3x 13
302809* 30G x ½ 0.3x 13
304100 24G x 1 0.55 x 25
304300 26G x 5/8 0.45 x 16
304622 18G x 1½ 1.2 x 40
*Pharmaceutical Quality

Page 2 of 3


Donore Road,
Drogheda,
Co. Louth,
Ireland.
t: +353.(0)419871500
f: +353.(0)419839066
NON-STERILE NEEDLES (BULK)
PRODUCT DESCRIPTION
CATALOG No. (Imperial, inch) (S.I.) mm
300206 25G X 5/8 0.5 x 16
300284 21G X 5/8 0.8 x 16
300403 25G X 1 0.5 x 25
300801 23G X 1 0.6 x 25
300802 21G X 1 ½ 0.8 x 40
300806 21G X 1 0.8 x 25
300807 20G X 1 0.9 x 25
300808 20G X 1 ½ 0.9 x 40
300901 22G X 1 ¼ 0.7 x 30
300932 30G X ½ 0.3 x 13
301296 27G X ½ 0.4 x 13
301530 19G X 1½ 1.1 x 40
302424 14G X 1 ¼ 2.1 x 30
303803 26G X ½ 0.45 x 13
304623 26G X 3/8 0.45 x 10
304627 23G X 1 0.6 x 25
304630 21G X 2 0.8 x 50
304636 18G X 2 1.2 x 50
304637 27G X ¾ 0.4 x 19
304641 24G X 1 0.55 x 25
304644 18G X 1½ SB TW 1.2 x 40
304728 22G X 1 0.7 x 25
304729 22G X 1½ 0.7 x 40
305146 23G X 1 ¼ 0.6 x 30
306030 25G X 5/8 0.5 x 16

Page 3 of 3


BD SafetyGlide Needles ™
and Syringes
Safety Without
Compromise
Setting the standard in
safety for a wide variety
of applications.
The most versatile safety injection
technology available today.
• Features single-handed activation that allows for ease of use
and minimal training.
• Low profile safety mechanism remains discretely out of the way before
and during injection and requires minimal change in technique.
• Activation-Assist™ technology minimizes finger motion required
for activation and keeps fingers behind the needle tip.
• Stainless-steel housing securely shields the needle tip after activation.
• Bevel-up design facilitates ease of injection. Safety-arm is
positioned for optimum visualization of injection site.
• Available in a full array of sizes.
• Compatible with any size conventional syringe.
Needles and Syringes

BD SafetyGlide Needles and Syringes ™
Prior to activation
BD Activation-Assist™ Detachable needles
technology for fast and fit on any size
easy needle tip shielding. conventional syringe.
Bevel-up needle orientation for

performing low angle injections.
After activation
Stainless steel latch securely
shields needle tip after activation.
BD SafetyGlide™ Needles 3 mL Syringes with BD SafetyGlide™ Needles

PROD # Description Packaging PROD # Description Packaging
305921 27 GA x 5/8 in. Needle 50/box, 500/case 305924 25 GA x 1 in. Needle 50/Box, 400/Case
305901 25 GA x 5/8 in. Needle 50/box, 500/case 305904 25 GA x 5/8 in. Needle 50/Box, 400/Case
305916 25 GA x 1 in. Needle 50/box, 500/case 305905 23 GA x 1 in. Needle 50/Box, 400/Case
305902 23 GA x 1 in. Needle 50/box, 500/case 305906 22 GA x 1 1/2 in. Needle 50/Box, 400/Case
305900 22 GA x 1 1/2 in. Needle 50/box, 500/case 305909 21 GA x 1 1/2 in. Needle 50/Box, 400/Case
305915 21 GA x 1 in. Needle 50/box, 500/case
305917 21 GA x 1 1/2 in. Needle 50/box, 500/case
305918 18 GA x 1 1/2 in. Needle 50/box, 400/case 5 mL Syringes with BD SafetyGlide™ Needles
PROD # Description Packaging
1 mL Syringes with BD SafetyGlide™ Needles 305907 22 GA x 1 1/2 in. 50 Box, 400/Case

305927 27 GA x 5/8 in. Needle 50/box, 400/case 10 mL Syringes with BD SafetyGlide™ Needles
305903 25 GA x 5/8 in. Needle 50/box, 400/case
305908 22 GA x 1 1/2 in. 50 Box, 400/Case

BD SafetyGlide Syringe ™
Safety
In Small Doses
Completes the SafetyGlide line
to meet your Subcutaneous and
Intradermal injection needs.
Available in three small syringe sizes–1 mL, 1⁄2 mL and 3⁄10 mL.
• 26 GA to 31 GA needle sizes perform a variety of subcutaneous and intradermal applications.
• 1 mL, 1⁄2 mL and 3⁄10 mL insulin syringe sizes facilitate small dose injections.
• Permanently attached needle means minimal waste space:
– A necessity for insulin injection.
– A potential medication cost savings if used instead of a detachable needle and syringe.
• Features single-handed activation that allows for ease of use and minimal training.
• Rotating safety arm eliminates interference with scale during drawing up, and
facilitates low-angle injections.
• Cap is designed to stand on end for true one-handed passive recapping of clean
needles for transport.
BD SafetyGlide Syringe ™
for Insulin, TB or Allergy
Prior to activation
Permanently Rotation of safety Clear scale

attached arm allows for visualization
needle bevel-up orientation
After activation
Needle tip is Safety arm can be

securely covered activated with one hand
after activation
BD SafetyGlide Needles with

Syringes for Insulin, TB or Allergy
305930 1 mL Insulin Syringe with 29 GA x 1⁄2 in. Needle 100/Box 400/Case
305932 1/2 mL Insulin Syringe with 29 GA x 1⁄2 in. Needle 100/Box 400/Case
305934 1/2 mL Insulin Syringe with 30 GA x 5⁄16 in. Needle - Thinwall 100/Box 400/Case
305935 3/10 mL Insulin Syringe with 29 GA x 1⁄2 in. Needle 100/Box 400/Case
305937 3/10 mL Insulin Syringe with 31 GA x 5⁄16 in. Needle - Thinwall 100/Box 400/Case
305945 1 mL Tuberculin Syringe with 27 GA x 1⁄2 in. Needle (RB) 100/Box 400/Case
305946 1 mL Tuberculin Syringe with 26 GA x 3⁄8 in. Needle (ID) 100/Box 400/Case
305950 Allergist Tray: 1 mL Syringe with 27 GA x 1⁄2 in. Needle (RB) 25/Tray 1000/Case
305951 Allergist Tray: 1 mL Syringe with 26 GA x 3⁄8 in. Needle (ID) 25/Tray 1000/Case
(RB) = Regular bevel

(ID) = Intradermal bevel

BD Integra ™
Shaping the
Future of Safety
The latest innovation
in retracting technology.
The only retracting syringe
that truly meets your clinical needs.
• It’s the first spring-based retracting syringe with a detachable needle!
Allows the clinician to change needles for aspiration and administration.
• The BD Integra™ Syringe has extremely low waste space. Low waste space
reduces medication waste and cost.1
Red area = waste space
The BD Integra Syringe has up to

86% less waste space than other
manufacturers’ syringe designs.
• The clinician decides when to activate the retracting mechanism either

before or after needle is withdrawn from patient.
• The low waste space design means there is minimal splatter after activation.
• Available in a wide range of needle gauges for use with 3mL syringes
for Intramusular, Subcutaneous and Intradermal injections.
Visit www.bd.com/Integra for more information.
1 Data on file.
Texas childrens white paper: Recent studies show that Integra can obtain more doses from multi-dose vials of flu vaccine.

BD Integra ™
With Retracting BD PrecisionGlide™ Needle
Prior to activation
BD PrecisionGlide™
Clear Barrel
Wide Flanges Needle Technology
For dosing accuracy
For comfort and stability “World Class Sharpness”
Single-Handed
Activation Detachable Needle
Tru-Lok Technology
Ensures low waste space and a reliable connection
After activation
eedle Retracts into the Syringe!

N
– Eliminates exposure to the needle after activation
BD Integra™ 3 mL Syringe
The BD Integra™ Syringe with detachable needle provides the benefit of low
waste space, which is important in reducing medication waste and costs.
BD Integra™ Needles
305269 3 mL Syringe with Detachable 25 GA x 5/8 in. Needle 100/box, 400/case 305310 25 GA x 5/8 in. Retracting Needle 100/box, 1000/case
305270 3 mL Syringe with Detachable 25 GA x 1 in. Needle 100/box, 400/case 305311 25 GA x 1 in. Retracting Needle 100/box, 1000/case
305271 3 mL Syringe with Detachable 23 GA x 1 in. Needle 100/box, 400/case 305312 23 GA x 1 in. Retracting Needle 100/box, 1000/case
305272 3 mL Syringe with Detachable 22 GA x 1 1/2 in. Needle 100/box, 400/case 305313 22 GA x 1 1/2 in. Retracting Needle 100/box, 1000/case
305273 3 mL Syringe with Detachable 21 GA x 1 in. Needle 100/box, 400/case 3052751 18 GA x 1 1/2 in. Blunt Fill Needle 100/box, 1000/case
305274 3 mL Syringe with Detachable 21 GA x 1 1/2 in. Needle 100/box, 400/case 3058331 18 GA x 1 1/2 in. Blunt Fill Needle with Filter 50/box, 500/case
1
– 18 GA Blunt Fill and Blunt Filter Needles have nonretracting needles.
BD Integra™ 3 mL Syringe Only

305283 3 mL Syringe Only 100/box, 400/case

BD Eclipse Injection Needle™
Safety
Made Simple
Intuitive and easy to use —
a highly economical
approach to safety.
The same technology for both
skin injection and blood collection.
• Activates with a single finger stroke immediately
after injection–no hard surface is required.
• Bevel-up design facilitates ease of injection.
Safety-arm is positioned for optimum visualization
of injection site.
• Wide, textured finger pad provides safe
activation area for thumb or forefinger.

BD Eclipse ™
Prior to activation
Wide-textured finger pad provides safe
activation area for thumb or forefinger
Bevel-up oriented Standard hub fits all

needle allows Luer Lock syringes
for low-angle injections
After activation
Needle remains locked
inside activated cover
BD Eclipse™ Needles 3 mL BD Luer-Lok™ Syringe

With this single-handed, needle-based safety-engineered injection with Detachable Needle
device, BD offers one technology for both injection and blood-collection PROD # Description Packaging
applications. The needle is bevel-up oriented to the safety 305781 25 GA x 5/8 in. 50/box, 300/case
cover to facilitate low-angle injections. 305787 25 GA x 1 in. 50/box, 300/case
305782 23 GA x 1 in. 50/box, 300/case
PROD # Description Packaging 305788 22 GA x 1 in 50/box, 300/case
305757 30 GA x 1/2 in. Needle 100/box, 1200/case 305783 22 GA x 1 1/2 in. 50/box, 300/case
305758 27 GA x 1/2 in. Needle 100/box, 1200/case 305779 21 GA x 1 in. 50/box, 300/case
305767 25 GA x 1 1/2 in. Needle 100/box, 1200/case 305784 21 GA x 1 1/2 in. 50/box, 300/case
305759 25 GA x 5/8 in. Needle 100/box, 1200/case
305762 23 GA x 1 in. Needle 100/box, 1200/case 5 mL BD Luer-Lok™ Syringe with Detachable Needle
305763 22 GA x 1 1/2 in Needle 100/box, 1200/case
305785 22 GA x 1 1/2 in. 50/box, 300/case
10 mL BD Luer-Lok™ Syringe with Detachable Needle
BD Eclipse™ Needles with SmartSlip™ Technology* 305786 22 GA x 1 1/2 in. 50/box, 300/case

305771 30 G x 1/2 in. 100/box, 1200/case
305770 27 G x 1/2 in. 100/box, 1200/case
305760 25 G x 5/8 in. 100/box, 1200/case
305778 30 GA x 1/2 in. 50/box, 300/case
305789 27 GA x 1/2 in. 50/box, 300/case
305780 25 GA x 5/8 in. 50/box, 300/case
*Designed for use with Luer Slip Syringes

BD Safety-Lok Syringe ™
First In Safety
The world’s first
safety-engineered syringe.
Proven performance and dependability.
• The only device of its kind to provide color-coded visual
confirmation of the safety lock.
• Protective sleeve locks into position with one motion to
cover the needle after injection.
• Crystal-clear barrel and sleeve allows for dosing visualization.
• Large flanges and tapered plunger rod increase control for
easier aspiration and injection.
• Interim “park” position of safety shield complements injection
practice in the OR.
• Can be used with any needle 1-1/2 in. or shorter – providing
safety for many sizes that do not have other alternatives.
• Available in a wide array of sizes–1 mL, 3 mL, 5 mL and 10 mL.

BD Safety-Lok Syringe ™
Prior to activation
Large Flanges and Crystal Clear Barrel and Sleeve make

Tapered Plunger Rod syringe contents easier to see
increase control for
easier aspiration and Bold Scale Markings World Class Sharpness
injection facilitate accurate dose for patient comfort
measurement
After activation Visual Lock Indicator

Lock confirmed when green
band fully covers red collar
(Also hear and feel the “lock”)
BD Safety-Lok™ Syringe
The only safety-engineered syringe of its type to offer clear visual
confirmation of the lock position.

329464 1 mL Insulin Syringe with Permanently Attached 100/box, 500/case
29 GA x 1/2 in. BD Ultra-Fine™ Needle (U-100)
305553 1 mL Tuberculin Syringe with Permanently Attached 100/box, 500/case
27 GA x 1/2 in. Needle
305554 1 mL Tuberculin Syringe with Permanently Attached 100/box, 500/case
25 GA x 5/8 in. Needle
309606 3 mL Syringe only 100/box, 800/case
309592 3 mL Syringe with 25 GA x 5/8 in. Needle 100/box, 800/case
309594 3 mL Syringe with 23 GA x 1 in. Needle 100/box, 800/case
309593 3 mL Syringe with 22 GA x 1 1/2 in. Needle 100/box, 800/case
309596 3 mL Syringe with 22 GA x 1 in. Needle 100/box, 800/case

BD™ Syringes and Needles
1 mL Tuberculin Syringe 305193 23 GA x 1 in. Thin Wall 100/shelf pack, 1000/case
305194 23 GA x 1 1/2 in. Thin Wall 100/shelf pack, 1000/case
PROD # Description Packaging 305155 22 GA x 1 in. 100/shelf pack, 1000/case
309602 TB Syringe Without Needle, Slip Tip 100/shelf pack, 800/case 305156 22 G x 1 1/2 in. 100/shelf pack, 1000/case
305165 21 GA x 1 in. 100/shelf pack, 1000/case
1 mL Luer-Lok™ Syringe Only 305167 21 GA x 1 1/2 in. 100/shelf pack, 1000/case
305177 21 GA x 1 in. Thin Wall 100/shelf pack, 1000/case
309628 BD Luer-Lok™ 1/100 mL 100/box, 800/case
309629 U-100 Insulin 100/box, 800/case
305176 20 GA x 1 1/2 in. 100/shelf pack, 1000/case
305186 19 GA x 1 in. Thin Wall 100/shelf pack, 1000/case
3 mL Syringe Only 305187 19 GA x 1 1/2 in. Thin Wall 100/shelf pack, 1000/case
309586 3 mL Syringe, Slip Tip 100/shelf pack, 800/case
305185 18 GA x 1 1/2 in. Thin Wall 100/shelf pack, 1000/case
309585 3 mL Syringe, BD Luer-Lok™ Tip 100/shelf pack, 800/case
5 mL Syringe Only
PROD # Description Packaging BD PrecisionGlide™ Needles Short Bevel
301603 5 mL Syringe, Slip Tip 100/shelf pack, 400/case
305178 20 GA x 1in. 100/shelf pack, 1000/case
10 mL Syringe Only 305179 20 GA x 1 1/2 in. 100/shelf pack, 1000/case
PROD # Description Packaging 305188 19 GA x 1 in. Thin Wall 100/shelf pack, 1000/case
301604 Slip Tip 100/box, 400/case 305189 19 GA x 1 1/2 in. Thin Wall 100/shelf pack, 1000/case
309604 BD Luer-Lok™ Tip 1/5 mL 100/box, 400/case 305199 18 GA x 1 1/2 in. 100/shelf pack, 1000/case
305482 Eccentric Tip 100/box, 400/case
309695 BD Luer-Lok™ Tip, Control Syringe 25/box, 100/case 1 mL Tuberculin Syringe with Needle
305462 Lab Syringe, Eccentric Tip, Non-Sterile 100/box, 400/case
309623 TB Syringe with 27 GA x 1/2 in. Needle 100/shelf pack, 800/case
20 mL Syringe Only 309625 TB Syringe with 26 GA x 3/8 in. Needle 100/shelf pack, 800/case
PROD # Description Packaging 309626 TB Syringe with 25 GA x 5/8 in. Needle 100/shelf pack, 800/case
301625 20 mL Syringe, Slip Tip 40/shelf pack, 160/case 309624 TB Syringe with 21 GA x 1 in. Needle 100/shelf pack, 800/case
300613 20 mL Syringe, Eccentric Tip 120/shelf pack, 480/case 3 mL Syringe with Detachable Needle
30 mL Syringe Only 309582 3 mL Syringe, 25 GA x 1 1/2 in. Needle 100/shelf pack, 800/case
PROD # Description Packaging 309581 3 mL Syringe, 25 GA x 1 in. Needle 100/shelf pack, 800/case
309651 30 mL Syringe, Slip Tip 40/shelf pack, 160/case 309570 3 mL Syringe, 25 GA x 5/8 in. Needle 100/shelf pack, 800/case
309650 30 mL Syringe, BD Luer-Lok™ Tip 40/shelf pack, 160/case 309571 3 mL Syringe, 23 GA x 1 in. Needle 100/shelf pack, 800/case
309574 3 mL Syringe, 22 GA x 1 1/2 in. Needle 100/shelf pack, 800/case
309573 3 mL Syringe, 22 GA x 1 1/4 in. Needle 100/shelf pack, 800/case
60 mL Syringe Only 309569 3 mL Syringe, 22 GA x 3/4 in. Needle 100/shelf pack, 800/case
PROD # Description Packaging 309572 3 mL Syringe, 22 GA x 1 in. Needle 100/shelf pack, 800/case
309654 60 mL Syringe, Slip Tip 40/shelf pack, 160/case 309575 3 mL Syringe, 21 GA x 1 in. Needle 100/shelf pack, 800/case
309653 60 mL Syringe, BD Luer-Lok™ Tip 40/shelf pack, 160/case 309578 3 mL Syringe, 20 GA x 1 in. Needle 100/shelf pack, 800/case
300866 60 mL Syringe, Eccentric Tip 60/shelf pack, 240/case
2 oz Catheter Tip Syringe Only (with Tip Shield) BD™ Blunt Fill Needles
309620 Catheter Tip 40/box, 160/case Blunt Fill Needles
BD PrecisionGlide™ Needles Regular Bevel 305180 BD™ Blunt Fill Needle 18 GA x 1 1/2 in. 100/box, 1000/case
305211 BD™ Blunt Filter Needle 18 GA x 1 1/2 in. 100/box, 1000/case
305106 30 GA x 1/2 in. 100/shelf pack, 1000/case
305128 30 GA x 1 in. 100/shelf pack, 1000/case 3 mL Syringe with BD Blunt Fill Needle
301629 27 GA x 1 1/2 in. 100/shelf pack, 1000/case PROD # Description Packaging
305109 27 GA x 1/2 in 100/shelf pack, 1000/case 305060 BD Luer-Lok™ Tip 3 mL with 18 GA x 1 1/2 in. 100/box, 800/case
305136 27 GA x 1 1/4 in. 100/shelf pack, 1000/case Blunt Fill Needle
305111 26 GA x 1/2 in. 100/shelf pack, 1000/case 5 mL Syringe with BD Blunt Fill Needle
305124 25 GA x 7/8 in. 100/shelf pack, 1000/case PROD # Description Packaging
305122 25 GA x 5/8 in. 100/shelf pack, 1000/case 305062 BD Luer-Lok™ Tip 5 mL with 18 GA x 1 1/2 in. 100/box, 400/case
Blunt Fill Needle
305145 23 GA x 1 in. 100/shelf pack, 1000/case 10 mL Syringe with BD Blunt Fill Needle
305143 23 GA x 3/4 in. 100/shelf pack, 1000/case PROD # Description Packaging
305064 BD Luer-Lok™ Tip 10 mL with 18 GA x 1 1/2 in. 100/box, 400/case
continued on top of next column ---> Blunt Fill Needle
Needles and Syringes 13

Pharmacy Products
BD™ Filter Needles BD Oral Syringe System
BD Filter Needles feature a molded-in 5 Micron filter membrane to reduce the Recommended for oral medications for
risk of aspirating glass particles when preparing medications from ampoules. patient safety. BD offers a broad range
of syringes and accessories for oral
PROD # Description Packaging medication administration. Both clear and
305200 19 GA x 1 1/2 in., Thin Wall 5 Micron filter 100/box, 1000/case amber syringes feature mL and teaspoon
305201 18 GA x 1 1/2 in., Thin Wall 5 Micron filter 100/box, 1000/case
with BD Nokor™ point scale markings for accuracy. The amber
syringes meet USP requirements for
photo-sensitive medications.
BD Nokor™ Vented Needles
The BD Nokor needle design features a cannula side port to place fluid on PROD # Description Packaging
the side wall of a container during reconstitution. Some drug manufacturers 305217 1 mL Syringe, Clear with Tip Cap 100/box, 500/case
recommend this to help reduce foaming or spray of powdered medication. 305220 3 mL Syringe, Clear with Tip Cap 100/box, 500/case
305218 5 mL Syringe, Clear with Tip Cap 100/box, 500/case
• BD Nokor design eliminates clogged 305219 10 mL Syringe, Clear with Tip Cap 100/box, 500/case
cannula, retaining venting capability 305207 1 mL Syringe, Amber with Tip Cap 100/box, 500/case
305210 3 mL Syringe, Amber with Tip Cap 100/box, 500/case
• Vented needles available, designed to 305208 5 mL Syringe, Amber with Tip Cap 100/box, 500/case
reduce internal container pressure 305209 10 mL Syringe, Amber with Tip Cap 100/box, 500/case

305213 16 GA x 1 in., Thin Wall Non-Coring Vented Needle 100/box, 1000/case BD Tamper-Tuf™ Medication Containers
305214 18 GA x 1 in., Thin Wall Non-Coring Vented Needle 100/box, 1000/case
BD Tamper-Tuf containers are offered in two sizes (15 mL or 30 mL) providing
extra convenience with a large filling port, snap-top and volume markings.
BD Nokor™ Admix Needles The containers are available unassembled for non-liquid and liquid oral
medication or assembled for liquid medication.
305216 16 GA x 1 in. Admix non-coring Needle with thin wall 100/box, 1000/case
305203 15 mL Container, Assembled 250/case
BD™ Sterile Syringe 305204 30 mL Container, Assembled 250/case
305205 15 mL Container, Unassembled 250/case
Convenience Trays 305206 30 mL Container, Unassembled 250/case
Efficiency for batch filling. With
features like a stopper at the bottom-
most position to reduce manipulation, BD Cornwall™
BD Sterile Syringe Convenience Trays Disposable Syringe System
help pharmacy staff save time and Comfortable, convenient fluid dispensing.
effort when batch-preparing syringes. The BD Cornwall Disposable Syringe System
offers a user-friendly design for fluid transfer
– without the capital investment required
309701 1 mL Syringe, BD Luer-Slip™ Tip 25/tray, 12 trays/case of 300
309702 3 mL Syringe, BD Luer-Lok™ Tip 25/tray, 12 trays/case of 300
for filling pumps. Optional syringe-filling
309703 5 mL Syringe, BD Luer-Lok™ Tip 25/tray, 12 trays/case of 300 connectors allow fluid transfer to a wide variety
309605 10 mL Syringe, BD Luer-Lok™ Tip 20/tray, 12 trays/case of 240 of reservoirs, including vials, syringes and oral
305617 20 mL Syringe, BD Luer-Lok™ Tip 10/tray, 12 trays/case of 120 medication containers.

BD Tip Caps 305224 10 mL Fluid BD Cornwall Disposable Syringe 10/case
305225 Syringe Tip Connector 50/case
PROD # Description Packaging 305223 Oral Syringe Tip Connector 50/case
308341 Luer Tip Cap Trays 10/tray, 200 trays, 2000/case
305819 Syringe Tip Cap 200/box, 2000/case

Diabetes Products
BD™ Insulin Syringes
3/10 mL BD Lo-Dose™ Insulin Syringe

309300 28 GA x 1/2 in U-100 BD Micro-Fine™ IV Self-Contained,
10ea/bag, 200/box, 1,600/case
309301 29 GA x 1/2 in U-100 BD Ultra-Fine™ Self-Contained
10ea/bag, 200/box, 1,600/case
1/2 mL BD Lo-Dose Insulin Syringe with

Permanently Attached Needle
329461 28 GA x 1/2 in U-100 BD Micro-Fine IV (Orange) Blister, 100/box, 500/case
309305 28 GA x 1/2 in U-100 BD Micro-Fine IV (Orange) 200/box, 1,600/case
309306 29 GA x 1/2 in U-100 BD Ultra-Fine 200/box, 1,600/case
1 mL BD Insulin Syringe with

Permanently Attached Needle
309309 28 GA x 1/2 in U-100 BD Micro-Fine IV (Orange) Self-Contained, 200/box, 1,600/case
309311 29 GA x 1/2 in U-100 BD Ultra-Fine Self-Contained, 200/box, 1,600/case
329424 28 GA x 1/2 in U-100 BD Micro-Fine IV (Orange) Blister, 100/box, 500/case
329420 28 GA x 1/2 in U-100 BD Micro-Fine IV Blister, 100/box, 500/case
Single unit Gradation

329651 25 GA x 5/8 in U-100 (Orange/Blue) Blister, 100/box, 800/case
329652 26 GA x 1/2 in U-100 (Orange/Tan) Blister, 100/box, 800/case
329622 25 GA x 1 in U-100 (Orange/Blue) Blister, 100/box, 800/case
1 mL BD Insulin Syringe Only

329650 U-100 Slip Tip (Orange) Blister, 100/box, 800/case
309629 U-100 Luer Lock Blister, 100/box, 800/case

BD™ Reusable Products
BD Regular Bevel Metal Hub - Nickel Chrome Plated BD Reusable Syringe Individual Packages
511252 30 GA 1/2 in. 12/box 512300 2 mL BD Yale Glass Syringe with Glass Luer Tip 1 ea
511258 30 GA 1-1/2 in. 12/box 512310 2 mL BD Yale Glass Syringe with Luer-Lock™ Tip 1 ea
511005 27 GA 1 in. 12/box 512306 3 mL BD Yale Glass Syringe with Glass Luer Tip 1 ea
511012 26 GA 1/2 in. 12/box 512316 3 mL BD Yale Glass Syringe with Luer-Lock™ Tip 1 ea
511023 25 GA 5/8 in. 12/box 512301 5 mL BD Yale Glass Syringe with Glass Luer Tip 1 ea
511028 25 GA 2 in. 12/box 512311 5 mL BD Yale Glass Syringe with Luer-Lock™ Tip 1 ea
511047 23 GA 1-1/2 in. 12/box 512302 10 mL BD Yale Glass Syringe with Glass Luer Tip 1 ea
511057 22 GA 1-1/2 in. 12/box 512303 20 mL BD Yale Glass Syringe with Glass Luer Tip 1 ea
511078 20 GA 2 in. 12/box 512317 100 mL BD Yale Glass Syringe with Luer-Lock™ tip 1 ea
511089 19 GA 3 in. 12/box
511097 18 GA 1-1/2 in. 12/box
511098 18 GA 2 in. 12/box BD Multifit™ Syringe Bulk Package
511108 15 GA 3-1/2 in. 12/box
511110 13 GA 3-1/2 in. 12/box PROD # Description Packaging
512440 2 mL glass syringe 36/box
BD Short Bevel Metal Hub - Nickel Chrome Plated 512442 10 mL glass syringe 36/box
PROD # Description Packaging 512444 30 mL glass syringe 36/box
511104 16 GA 2 in. 12/box 512445 50 mL glass syringe 36/box

511109 13 GA 2 in. 12/box

Adaptors
BD Tuberculin Syringe, Precision with Glass Luer Tip
PROD # Description Packaging 513095 470V-1 modified two-way automatic valve-AT shaped 1 ea
512001 1/4 Yale Tuberculin 1/4 mL in. 1/100 mL and 1/2 min. 1 ea with female BD Luer-Lok™ and female BD Luer-Lok™
side connection (non-return type)
512002 1/2 Yale Tuberculin 1/2 mL in. 1/100 mL and 1/2 min. 1 ea
512004 1 Yale Tuberculin 1 mL in. 1/100 mL and 1/2 min. 6 ea 513113 mLL/ mLL adapter male Luer to male Luer 1 ea
512027 1YTL 1 mL BD Luer-Lok™ Tip 1 ea 513328 470F Fistula Tip 1 ea
513397 470W-Black Buna-N rubber washer for (470V and 3410V) 12/box
512019 2YB 2 mL in. 1/20 mL 1 ea
513576 470RVS Set-Four Buna-N rubber valve tacks and 1 ea
2 stainless steel springs
519067 Male BD Luer-Lok™ adapter 1 ea
BD Multifit™ Reuseable Syringes 513560 1220FO filling outfit, includes 470v valve, 20 in. 1 ea
470t tubing, 330S metal sinker
512140 2 mL BD Multifit Reusable Syringe 1 ea
Reuseable Anesthesia Needles
512142 10 mL BD Multifit Reusable Syringe 1 ea PROD # Description Packaging

511118 LLX extension Needle 1 ea
511140 20 GA x 4 in. BD Yale™ Quincke spinal Needle 1 ea
BD Cornwall™ Control Syringe with BD Luer Lok Tip™ 511168 23 GA x 1/2 in. curved tonsil Needle 1 ea
PROD # Description Packaging 511169 23 GA x 3/4 in. straight tonsil Needle 1 ea
512190 1240S 1 mL 1 ea 511219 17 GA x 3 in. Tuohy epidural Needle, thin wall 1 ea
512191 1250S 2 mL 1 ea 511285 17 GA x 7 in. Tuohy epidural Needle, thin wall 1 ea
512192 1260S 5 mL 1 ea 511317 20 GA x 5 in. Pudendal and Parasympathetic block Needle 1 ea
512193 1270S 10 mL 1 ea 511318 19 GA x 5 in. Pudendal and Parasympathetic block Needle 1 ea
512907 10 mL BD Multifit™ glass control syringe with BD Luer-Lok™ Tip 1 ea 511319 20 GA x 6 in. Pudendal Parasympathetic nerve block Needle 1 ea
511320 18 GA x 6 in. Pudendal and Parasympathetic block Needle 1 ea
511364 20 GA x 6 in. BD™ local anesthesia security bead Needle 1 ea

Reusable Biopsy Needles

Legend: Syringe Tip Abbreviations PROD # Description Packaging
511348 18 GA x 1 in. bone marrow aspiration and transfusion Needle 1 ea
MULTIFIT YALE
511346 16 GA x 1 5/16 in. bone marrow aspiration and transfusion Needle 1 ea
mLL……Luer-Lock Tip YL……Luer-Lock Tip 511403 16 GA x 4 in. Liver, kidney and soft tissue 1 ea
MM…...Metal Luer Tip Y……..Glass Luer Tip 511547 14 GA x 4 1/2 in. Liver, kidney and soft tissue 1 ea
511548 14 GA x 3 3/8 in. Liver, kidney and soft tissue 1 ea
M……..Glass Luer Tip YM…...Metal Luer Tip
MLC….Luer-Lock, Control YE……Glass Luer Eccentric Tip
YLE…..Luer-Lock Eccentric Tip

BD Micro-Fine™ +, BD Micro-Fine™ Plus Insulin Syringes
BD Medical – Diabetes Care

Becton Dickinson France S.A.S.
11, rue Aristide Bergès, BP 4
38801 Le Pont-de-Claix Cedex
France
TECHNICAL DATA SHEET

Sterile, Single use, Latex Free
GENERAL INFORMATION
BD insulin syringes are a sterile, single use device designed for the parenteral
administration of pharmaceuticals.
U40 insulin syringes Self-contained (sterile interior) with red color needle
shield and printed scale mark:
Reference Volume External Needle Polybag Shelf box Shipping

Diameter Length (units) (units) box
(units)
320722 1ml 30G 8mm 10 100 500
320801 1ml 29G 12,7mm 10 100 500
320910 1ml 29G 12,7mm 10 100 500
320911 1ml 30G 8mm 10 100 500
324876 0,5ml 30G 8mm 10 100 500
U-100 Insulin syringes – Self-contained (sterile interior) with orange color

needle shield and black printed scale mark:

(units)
320804 0,5ml 29G 12,7mm 10 100 500
320806 0,5ml 29G 12,7mm 10 100 500
320812 0,5ml 29G 12,7mm 10 10 500
320829 0,3ml 30G 8mm 10 100 500
320830 0,3ml 30G 8mm 10 100 500
320837 0,3ml 30G 8mm 10 100 500
320838 0,3ml 30G 8mm 10 100 500
320839 0,3ml 30G 8 mm 10 100 500
320840 0,3ml 30G 8 mm 10 30 420
320841 1ml 29G 12,7mm 10 100 500
320842 0,5ml 29G 12,7mm 10 100 500
320843 0,5ml 30G 8mm 10 100 500
320909 1ml 29G 12,7mm 10 100 500
320924 1ml 29 G 12,7 mm 10 - 300
320926 0,5ml 29G 12,7 mm 10 - 300
320927 0,5ml 30G 8mm 10 - 300
320929 1ml 30G 8mm 10 100 500
320932 0,5ml 29G 12,7mm 10 100 500
320921 0,5ml 29G 12,7mm 10 100 500
320930 0,5ml 30G 8mm 10 100 500
August 2011 Page 1 of 4

320931 1ml 29G 12,7mm 10 100 500
320932 0,5ml 29G 12,7mm 10 100 500
320933 0,5ml 30G 8mm 10 100 500
320935 1ml 30G 8mm 10 100 500
324622 1ml 29G 12,7mm 10 - 300
324805 1ml 29G 12,7mm 10 100 500
324824 0,5ml 29G 12,7mm 10 100 500
324825 0,5ml 30G 8mm 10 100 500
324826 0,3ml 30G 8mm 10 100 500
324827 1ml 29G 12,7mm 10 100 500
324880 0,3ml 30G 8mm 10 30 420
324881 0,5ml 30G 8mm 10 30 420
324882 0,5ml 29G 12,7mm 10 30 420
324883 1ml 29G 12,7mm 10 30 420
324884 0,3ml 30G 8mm 10 100 500
326725 0,5ml 30G 8mm 10 100 500
U-100 Insulin syringes – Blister Pack :
Reference Volume External Needle Blisters in

Diameter Length Shipping box
324891 1ml 29G 12,7mm 200
324892 0,5ml 29G 12,7mm 200
324893 0,5ml 30G 8mm 200
324899 1ml 30G 8mm 200
The insulin syringes are designed for administering insulin in the treatment of
diabetes mellitus. The treatment may be carried out by a patient or by a healthcare
professional, either in the home setting, in a hospital, or a clinical setting.
GENERAL INFORMATION AND STANDARD
MATERIALS
Component Material
Cannula 304 Stainless Steel
Lubricant - Cannula Silicone Based
Barrel Polypropylene
Lubricant - Barrel Silicone Oil
Hub (applicable to 0,3ml and Polypropylene
0.5ml syringes only)
Adhesive -Ultraviolet Adhesive (0,3ml and 0.5ml syringes)
-Ultraviolet Adhesive or Oven Cure Epoxy (1ml
syringes)
Plunger Rod Polystyrene and Colorant
Stopper Polyisoprene
Shield Polyethylene and Colorant
Plunger Cap (self-contained Polyethylene
syringes only)

The products do not contain natural latex.
Based on information available and BD’s continuous data collection efforts

throughout the supply chain, BD has not identified any chemicals in the articles
and packaging with the Product Numbers as referenced above, in an individual
concentration above 0.1% weight by weight (w/w), which have been listed as
Substances of Very High Concern (SVHC) and included in the "Candidate List"
published by the European Chemical Agency (ECHA) on 28 October 2008,
according to Art. 59 (1, 10) of the Regulation (EC) N° 1907/2006 (REACH). The
substances published in such list are candidates for eventual inclusion in the List
of Substances Subject to Authorisation (Annex XIV of REACH). As such, these
products don't contain di-(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate
(BBP) or dibutyl phthalate (DBP) in concentrations above 0,1% of the total article.
LABELING: according to European Medical Device Directive
STERILIZATION: Radiation (gamma)
SHELF LIFE: 5 years after sterilization
STORAGE CONDITIONS: The long-term storage limitations of the product are

considered to be 4 to 40°C with capability to withstand short periods of exposure
(up to 2 weeks) at 60°C.
QUALITY CONTROL:
Incoming materials inspections are performed as per internal procedures. Where
required, raw materials are inspected against the appropriate certificate of
compliance for conformance prior to their use in manufacture.
During in-process inspection, individual components are inspected for appropriate
dimensional requirements as well as conformance to performance specifications.
There is also a 100% vision system that checks different parameters from the in-
process controls.
The manufacturing sites perform final inspections and data review of each lot
before release is performed.
STANDARDS:
ISO 8537:2007 Sterile, single-use syringes with or without needle, for insulin
injection

SITES IDENTIFICATION AND ADDRESSES
Name and Address Certification

Manufacturer: Becton Dickinson and Company Registered to ISO 13485:2003,
1 Becton Drive with BSI under file number FM
Franklin Lakes 513512
New Jersey 07417
USA
Authorized BD Medical – Diabetes Care

Representative: Becton Dickinson France S.A.S.
11, rue Aristide Bergès
BP 4
France
Manufacturing BD Medical Diabetes Care EN ISO 13485:2003 and EN

Site(s): 1329 West Highway 6 9001:2008 with NSAI under file
Holdrege, number MD19.1436.
Nebraska 68949-0860
USA
Sterilisation BD Medical Diabetes Care EN ISO 13485:2003 and EN

Site(s): 1329 West highway 6 9001:2008 with NSAI under file
Nebraska 68949-0860
USA
CE CERTIFICATION INFORMATION
NOTIFIED BODY NAME AND ADDRESS:

BD Micro-Fine™ Insulin Syringes are certified by:
National Standards Authority of Ireland (NSAI)
1 Swift Square
Northwood, Santry
Dublin 9
Ireland
Notified body number: 0050
MEDICAL DEVICE CLASSIFICATION:

The BD Micro-Fine™ Insulin Syringes are Class IIa medical devices as defined in
the Medical Devices Directive (93/42/EEC).
CE CERTIFICATE NUMBER: 252.140

BD Medical – Diabetes Care

Becton Dickinson France S.A.S.
11, rue Aristide Bergès, BP 4
France

Sterile, Single use, Latex Free
GENERAL INFORMATION
BD insulin syringes are a sterile, single use device designed for the parenteral
administration of pharmaceuticals.
U40 insulin syringes Self-contained (sterile interior) with red color needle
shield and printed scale mark:

(units)
320722 1ml 30G 8mm 10 100 500
320801 1ml 29G 12,7mm 10 100 500
320910 1ml 29G 12,7mm 10 100 500
320911 1ml 30G 8mm 10 100 500
324876 0,5ml 30G 8mm 10 100 500
U-100 Insulin syringes – Self-contained (sterile interior) with orange color

needle shield and black printed scale mark:

(units)
320804 0,5ml 29G 12,7mm 10 100 500
320806 0,5ml 29G 12,7mm 10 100 500
320812 0,5ml 29G 12,7mm 10 10 500
320829 0,3ml 30G 8mm 10 100 500
320830 0,3ml 30G 8mm 10 100 500
320837 0,3ml 30G 8mm 10 100 500
320838 0,3ml 30G 8mm 10 100 500
320839 0,3ml 30G 8 mm 10 100 500
320840 0,3ml 30G 8 mm 10 30 420
320841 1ml 29G 12,7mm 10 100 500
320842 0,5ml 29G 12,7mm 10 100 500
320843 0,5ml 30G 8mm 10 100 500
320909 1ml 29G 12,7mm 10 100 500
320924 1ml 29 G 12,7 mm 10 - 300
320926 0,5ml 29G 12,7 mm 10 - 300
320927 0,5ml 30G 8mm 10 - 300
320929 1ml 30G 8mm 10 100 500
320932 0,5ml 29G 12,7mm 10 100 500
320921 0,5ml 29G 12,7mm 10 100 500
320930 0,5ml 30G 8mm 10 100 500

320931 1ml 29G 12,7mm 10 100 500
320932 0,5ml 29G 12,7mm 10 100 500
320933 0,5ml 30G 8mm 10 100 500
320935 1ml 30G 8mm 10 100 500
324622 1ml 29G 12,7mm 10 - 300
324805 1ml 29G 12,7mm 10 100 500
324824 0,5ml 29G 12,7mm 10 100 500
324825 0,5ml 30G 8mm 10 100 500
324826 0,3ml 30G 8mm 10 100 500
324827 1ml 29G 12,7mm 10 100 500
324880 0,3ml 30G 8mm 10 30 420
324881 0,5ml 30G 8mm 10 30 420
324882 0,5ml 29G 12,7mm 10 30 420
324883 1ml 29G 12,7mm 10 30 420
324884 0,3ml 30G 8mm 10 100 500
326725 0,5ml 30G 8mm 10 100 500
U-100 Insulin syringes – Blister Pack :
Reference Volume External Needle Blisters in

Diameter Length Shipping box
324891 1ml 29G 12,7mm 200
324892 0,5ml 29G 12,7mm 200
324893 0,5ml 30G 8mm 200
324899 1ml 30G 8mm 200
The insulin syringes are designed for administering insulin in the treatment of
diabetes mellitus. The treatment may be carried out by a patient or by a healthcare
professional, either in the home setting, in a hospital, or a clinical setting.
GENERAL INFORMATION AND STANDARD
MATERIALS
Component Material
Cannula 304 Stainless Steel
Lubricant - Cannula Silicone Based
Barrel Polypropylene
Lubricant - Barrel Silicone Oil
Hub (applicable to 0,3ml and Polypropylene
0.5ml syringes only)
Adhesive -Ultraviolet Adhesive (0,3ml and 0.5ml syringes)
-Ultraviolet Adhesive or Oven Cure Epoxy (1ml
syringes)
Plunger Rod Polystyrene and Colorant
Stopper Polyisoprene
Shield Polyethylene and Colorant
Plunger Cap (self-contained Polyethylene
syringes only)

The products do not contain natural latex.
Based on information available and BD’s continuous data collection efforts

throughout the supply chain, BD has not identified any chemicals in the articles
and packaging with the Product Numbers as referenced above, in an individual
concentration above 0.1% weight by weight (w/w), which have been listed as
Substances of Very High Concern (SVHC) and included in the "Candidate List"
published by the European Chemical Agency (ECHA) on 28 October 2008,
according to Art. 59 (1, 10) of the Regulation (EC) N° 1907/2006 (REACH). The
substances published in such list are candidates for eventual inclusion in the List
of Substances Subject to Authorisation (Annex XIV of REACH). As such, these
products don't contain di-(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate
(BBP) or dibutyl phthalate (DBP) in concentrations above 0,1% of the total article.
LABELING: according to European Medical Device Directive
STERILIZATION: Radiation (gamma)
SHELF LIFE: 5 years after sterilization
STORAGE CONDITIONS: The long-term storage limitations of the product are

considered to be 4 to 40°C with capability to withstand short periods of exposure
(up to 2 weeks) at 60°C.
QUALITY CONTROL:
Incoming materials inspections are performed as per internal procedures. Where
required, raw materials are inspected against the appropriate certificate of
compliance for conformance prior to their use in manufacture.
During in-process inspection, individual components are inspected for appropriate
dimensional requirements as well as conformance to performance specifications.
There is also a 100% vision system that checks different parameters from the in-
process controls.
The manufacturing sites perform final inspections and data review of each lot
before release is performed.
STANDARDS:
ISO 8537:2007 Sterile, single-use syringes with or without needle, for insulin
injection

SITES IDENTIFICATION AND ADDRESSES
Name and Address Certification

Manufacturer: Becton Dickinson and Company Registered to ISO 13485:2003,
1 Becton Drive with BSI under file number FM
Franklin Lakes 513512
New Jersey 07417
USA
Authorized BD Medical – Diabetes Care

Representative: Becton Dickinson France S.A.S.
11, rue Aristide Bergès
BP 4
France
Manufacturing BD Medical Diabetes Care EN ISO 13485:2003 and EN

Site(s): 1329 West Highway 6 9001:2008 with NSAI under file
Nebraska 68949-0860
USA
Sterilisation BD Medical Diabetes Care EN ISO 13485:2003 and EN

Site(s): 1329 West highway 6 9001:2008 with NSAI under file
Nebraska 68949-0860
USA
CE CERTIFICATION INFORMATION
NOTIFIED BODY NAME AND ADDRESS:

BD Micro-Fine™ Insulin Syringes are certified by:
National Standards Authority of Ireland (NSAI)
1 Swift Square
Northwood, Santry
Dublin 9
Ireland
Notified body number: 0050
MEDICAL DEVICE CLASSIFICATION:

The BD Micro-Fine™ Insulin Syringes are Class IIa medical devices as defined in
the Medical Devices Directive (93/42/EEC).
CE CERTIFICATE NUMBER: 252.140

Becton Dickinson and Company A-One Business Centre
Z.A. Vers-la-Pièce n. 10
BD Medical CH-1180 Rolle
Switzerland
bd.com

BD Plastipak™ syringes without needles and
BD General Syringes without needle
Sterile, Single Use, Latex free
1. General Information
1.1 General
BD Plastipak™ syringes are used for general purpose injection and aspiration of fluids from vials,
ampoules and parts of the body below the surface of the skin. Perfusion syringes, 50ml syringes,
are designed for short term use in syringe pumps (active IIa devices) for the administration of
pharmaceuticals. The 50 ml Catheter Tip Syringes have a long tapered tip designed to aid in
irrigation or for connection to non-ISO compatible Luer connections such as nasogastric tubes.
DEAD SPACE (maximum, without needle) (except for catheter tip syringes)
SYRINGE SIZE 1 ml 2ml 5ml 10ml 20ml 30ml 50ml 100ml
Dead Space 0.07 ml 0.07ml 0.075ml 0.10ml 0.15ml 0.17ml 0.20ml 0.20ml
Switzerland
bd.com
Plastipak syringes without needles TDS version March 2016
LUER SLIP SYRINGES

Reference Capacity Description Scale Graduation Box (units) Case (units)
300026 1 ml Insulin 40 I.U. International units 100 800
300013 1 ml Central cone 0.01 ml 100 800
300185 2/ 2.5 ml Central cone 0.1 ml 100 800
302188 10 ml Eccentric cone 0.5 ml 100 400
301183 20 ml Eccentric cone 1 ml 60 240
300866 50/ 60 ml Eccentric cone 1 ml 60 240
300867 50/ 60 ml Catheter tip 1 ml 60 240
300605 100 ml Catheter tip with Luer adaptor 2 ml 25 50
309654 60ml Slip tip 1 ml 40 160
LUER LOK™ SYRINGES

301189 20 ml Luer Lok™ 1 ml 60 240
300629 20 ml Luer Lok™ 1 ml 120 480
301229 30 ml Luer Lok™ 1 ml 60 240
300865 50/60 ml Luer Lok™ 1 ml 60 240
300137 50 ml Luer Lok™ Perfusion 1 ml 50 100
300139 50 ml Luer Lok™ Perfusion Amber 1 ml 50 100
309653 60ml Luer Lok™ 1 ml 40 160
309628 1 ml Luer Lok™ 0.01 ml 100 800
309658 3ml Luer Lok™ 0.1ml 200 800
309649 5ml Luer Lok™ 0.2ml 125 500
300912 10ml Luer Lok™ 0.2ml 100 400
305959* 10ml Luer Lok™ 0.2ml 100 400
300869 50/ 60 ml Luer Lok™ AMBER 1 ml 60 240
*305959 will be preferred to supply to European customers as this catalogue number of 10ml Luer Lok™ Plastipak
is manufactured in Europe.
This document is approved electronically Page 2 of 13

This document can be changed without further notification
Switzerland
bd.com
1.2 Certification
BD BD ISO CE MARKING BD MANUFACTURING
REFERENCE MANUFACTURER CERTIFICATION SITE
301189 Becton Dickinson & NSAI - Certificate NSAI NB no Becton Dickinson S.A. -
301183 Company Limited MD 19.1609 I.S. EN 0050: Certifícate Camino de Valdeoliva, s/n.
300629 Donore Road ISO 13485:2012 N° 252.156 28750, San Agustin del
301229 Drogheda Guadalix (Madrid) Spain
300865 Co. Louth
300869 Ireland
300867
300605
300613
301231
300866
300137
300139
300026 Becton Dickinson AENOR –N. ER- AEMPS 0318: Becton Dickinson S.A. -
301355 S.A. - Camino de 0264/1994 – ISO Certifícate N° Camino de Valdeoliva, s/n.
300013 Valdeoliva, s/n. 9001:2008; 2000 06 0273 28750, San Agustin del
300185 28750, San Agustin CP Guadalix (Madrid) Spain
302187 del Guadalix (Madrid) AEMPS N. 2012 07
302188 Spain 0013 EN - EN – ISO
303172 13485:2013
303173
303174
305959
309628* Becton, Dickinson NSAI - ISO NSAI 0050: Becton, Dickinson and
309658 and Company 9001 :20008 Certifícate N° Company
309649 1 Becton Drive Certificate 252.231 Route 7 & Grace Way,
300910 Franklin Lakes, NJ MD19.2305 Canaan CT 06018
300911 07417, USA USA
300912 NSAI ISO
309653 13485 :2012
309654 Certificate
MD19.2305
*Catalogue number 309628 used to be manufactured in BD Singapore Branch, 30 Tuas Avenue 2, Singapore 639461.
No changes to form, fit or function when transferred to BD Canaan.

Switzerland
bd.com
1.3 Material
COMPONENT MATERIAL
SYRINGE
Barrels, plunger rods POLYPROPYLENE
Barrel cat# 309628 POLYCARBONATE
Stoppers LATEX FREE ELASTOMER
2
Lubricant MEDICAL GRADE SILICONE OIL, <0.25 mg/cm
AMBER syringes have the barrel colored to reduce U.V. light; for administration of light sensitive medications
PACKAGING
Web packaging POLYAMIDE/POLYETHYLENE, PAPER WITH MEDICAL GRADE
Ink Printing Ink
Box HARD PAPER
1.4 Material of concern

Materials of concern are chemicals or substances that have been identified as having the potential
to cause long term effects on humans or the environment.
MATERIAL COMMENT
Phthalates The products do not contain phthalates in general and as such the products do not contain
di (2ethylhexyl) phthalate DEHP as CAS number 117-81-7, EC number 204-211-0.
Latex The products do not contain natural latex.
Bisphenol A The products do not contain Bisphenol A.
Catalogue number 309628 contain polycarbonate and hence Bisphenol A
Substances of animal The products do use industrial raw materials which contain small amounts of tallow or
origin BSE/TSE tallow derivatives (e.g. stearates in polymers). Such substances are not considered as
derivatives of animal tissues for the purpose of this rule (EU regulation 722/2012) which
therefore does not apply
Polyvinyl chloride (PVC) The products do not contain polyvinyl chloride
1.5 REACH information

Based on information available and BD’s continuous data collection efforts throughout the supply
chain, BD have not identified any chemicals in the articles and packaging with the Product
Numbers as referenced above, in an individual concentration above 0.1% weight by weight
(w/w), which have been listed as SVHC and included in the "Candidate List" published by the
European Chemical Agency (ECHA. The substances published in such list are candidates for
eventual inclusion in the List of Substances Subject to Authorization (Annex XIV of REACH).
1.6 Biocompatibility
BD Medical products comply with the requirements of the standard for biocompatibility of
medical devices, ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and
Testing.

Switzerland
bd.com
1.7 Sterilization
 Ethylene Oxide Sterilization following EN ISO 11135-1. ETO residues are within
applicable regulations. All references except references below are sterilized with EO
 Radiation Sterilization following EN ISO 11137-1 References sterilized with radiation:
309628, 309658, 309649, 300910, 300911, 300912, 309653 and 309654.
1.8 Shelf life

Shelf life 5 years
No special storage or transportation condition. Recommendations to store in room temperature.
Store in dry and warm place and not exposed to strong light.
1.9 Standards
HARMONISED STANDARDS
Sterilisation of Medical Devices – requirements for medical devices to be labelled
EN 556-1:2001/ AC:2006
“sterile”.
EN 980: 2008 Graphical Symbols for use in the labelling of medical devices.
Terminology, symbols and information provided with medical devices. Information
BS EN 1041+A1: 2013
supplied by the manufacturer with medical devices
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
EN 1707:1996
equipment - Lock fittings
EN 20594- Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical
1:1993/AC:1996 equipment - Part 1: General requirements
EN IS010993-series Biological evaluation of medical devices
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for
EN ISO 11135-1:2007 development, validation and routine control of a sterilization process for medical
devices
EN ISO 11137-1 Sterilization of health care products - Radiation. Part1.Requirements for development,
validation and routine control of sterilization process for medical devices
EN ISO 11137-2 Sterilization of health care products – Radiation. Part2. Establishing the sterilization
dose
EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators
for ethylene oxide sterilization processes
Packaging for terminally sterilized medical devices - Part 1: Requirements for
EN ISO 11607-1:2009
materials, sterile barrier systems and packaging systems
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
EN ISO 11607-2:2006
forming, sealing and assembly processes
EN ISO 11737-
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a
1:2006/AC:2009
population of microorganisms on products
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility
EN ISO 11737-2:2009
performed in the definition, validation and maintenance of a sterilization process (ISO
11737-2:2009)

Switzerland
bd.com

HARMONISED STANDARDS, continue
EN ISO
Medical devices – Quality management Systems Requirements for Regulatory
13485:2012/AC:2012
Purposes
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
EN ISO 14971:2012 Medical Devices. Application of risk management to medical devices
NON HARMONISED STANDARD
IS EN ISO 7864-1: 1996 Sterile hypodermic needles For Single Use
IS EN ISO 7886-1:1998 Sterile hypodermic syringes For Single use - Part 1:Syringes for manual use
Sterile Hypodermic Syringes for Single Use. Part 2: Syringes for Use with Power-
EN ISO 7886-2:1998 Driven Syringe Pumps.
See notes 2 and 3 below
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical
ISO 594-1:1993
equipment - Part 1: General requirements
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
ISO 594-2:1998
equipment -- Part 2: Lock fittings
ISO 9626: 1995 Stainless steel needle tubing for the manufacture of medical devices
Medical devices – Quality management Systems Requirements for Regulatory
ISO 13485:2003
Purposes
Cleanrooms and associated controlled environments Part 1: Classification of air
ISO 14644-1:1999
cleanliness
Sterilisation of Medical Devices – requirements for medical devices to be labelled
ISO 15223-1:2012
“sterile”.
ISO 10993-2:2009 Biological Evaluation of Medical Devices Part 2
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-
ISO10993-10:2009
type hypersensitivity
Sampling procedures for inspection by attributes -- Part 1: Sampling schemes
ISO 2859-1:1999
indexed by acceptance quality limit (AQL) for lot-by-lot inspection
INSULIN GRADUATED SYRINGE ALSO MEETS ISO 8537 Sterile single-use syringes, with or without
needle, for insulin
1.10 Classification
 Class I Sterile with a measuring function (syringes from 1 to 10 ml) Medical Device
under Rule 2, Annex IX of Medical Devices Directive 93/42/EEC as amended.
 Class IIa (syringes from 20 to 50 ml) Medical Device under Rule 2, Annex V and VII IX
of Medical Devices Directive 93/42/EEC as amended.
1.11 GMDN code

GMDN code 47017: General purpose syringes.

Switzerland
bd.com

1.12 Good Manufacturing practices
The entire manufacturing and testing processes are following the Good Manufacturing Practices
as specified below
 Incoming raw materials are verified via material inspection and testing and our suppliers
are approved via our vendor management system.
 In addition to the automatic on-line inspections, in-process inspections are performed in
addition to final product testing to ensure compliance with approved specifications.
 The manufacturing and testing details of each batch of product are recorded on a batch
record which is retained in accordance with our document control procedures
 BD operates a system of Internal and external audits to maintain compliance
 BD confirms that it will continue to adhere to relevant international standards in designing
and manufacturing its products.
 BD reserves the right to use the internal change control procedure to change raw material
suppliers and production process
1.13 Others
 The EU representative, for syringes which BD Manufacturer is Becton, Dickinson and
Company, 1 Becton Drive, Franklin Lakes, NJ 07417, USA, is Becton Dickinson
Distribution Center, Laagstraat 57, B-9140 Temse -Belgium. Other syringes are produced
by a European manufacturer.
 (Material) Safety Data Sheets are not required for this product
 Certificate of Food Contact (COMMISSION REGULATION (EU) No. 10/2011 of January
14th, 2011 concerning materials and plastic objects intended to get in touch with
foodstuffs) is not required as BD products are used for general purpose injection and
aspiration of fluids from vials, ampoules and parts of the body below the surface of the
skin.

Switzerland
bd.com
2. Packaging
2.1 Packaging material

LABELS: according to European Medical Device directive, multilingual
2.2 Example labeling

Legal Manufacturer and manufacturing site: San Agustin del Guadalix
Example Unit pack cat.no 301355
Example Shelf box label cat.no 301355

Switzerland
bd.com
Shelf box graphics

Switzerland
bd.com
Legal Manufacturer: Drogheda/ Manufacturing site San Agustin del Guadalix
Example Shelf box label cat.no 300867

Switzerland
bd.com
Shelf box graphics

Switzerland
bd.com
Legal Manufacturer: Franklin Lakes, Manufacturing site Canaan
Exmaple Shelf box label cat.no 309628

Switzerland
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Shelf box graphics
----------------------------------------------------------------end of document----------------------------------------------------

Becton Dickinson and Company BD Switzerland Sàrl
BD Medical, Terre Bonne Park - A4
Medication and Procedural Solution Route de Crassier 17
1262 Eysins,
Switzerland
bd.com

BD Emerald™ Syringe with and without needle
Sterile, Single Use, Latex free
1. General Information
1.1 General
The BD Emerald™ syringe is a medical single use product for injection and/or aspiration of
medical fluids and drugs.
The 3-piece syringes BD Emerald™ are used with hypodermic needles, catheters, etc. For this
purpose they are connected with the needle hub or catheter, in a manner that they remain perfectly
fitted. Once the product has been used, the syringe must be discarded to avoid infection,
preferably using the disposal containers available in the market.
The 3-piece BD Emerald™ syringe with needle is a medical device for single use intended for
injection and/or aspiration of medical fluids, such as body fluids (blood) and medicinal
substances.
The 3-piece BD Emerald™ syringe with Blunt Fill needle is a medical device for single use
intended drug loading and not for skin injection.
1262 Eysins,
Switzerland
bd.com
Emerald syringe with and without needle, version November 2016
LUER SLIP SYRINGES WITHOUT NEEDLE

302986 3 ml Central cone 0.1ml 100 2400
LUER SLIP SYRINGES WITH PRE-ATTACHED NEEDLE (assembled)

Reference Capacity Description Scale Box Case
Graduation (units) (units)
Syr. Cone Gauge Lenght
307728 2 ml Central 22G 1 ¼” 0.1 ml 100 2000
307740 2 ml Central 23G 1” 0.1 ml 100 2000
307741 2 ml Central 23G 1 ¼” 0.1 ml 100 2000
307732 5 ml Central 21G 1 ½” 0.2 ml 100 1500
307733 5 ml Central 22G 1 ¼” 0.2 ml 100 1500
307735 5 ml Central 23G 1 ¼” 0.2 ml 100 1500
307737 10 ml Central 21G 1 ½” 0.2 ml 100 900
307738 10 ml Central 22G 1 ¼” 0.2 ml 100 900
LUER SLIP SYRINGES WITH PRE-ATTACHED BLUNT FILL NEEDLE (assembled)

Reference Capacity Description Scale Box Case
Graduation (units) (units)
Syr. Cone Gauge Lenght
303221 2 ml Central 18G 1 ½” 0.1 ml 100 2000
303139 5 ml Central 18G 1 ½” 0.2 ml 100 1500
303140 10 ml Central 18G 1 ½” 0.2 ml 100 900
DEAD SPACE (maximum, without needle) (except for catheter tip syringes)
Syringe size 2ml 3 ml 5ml 10ml
Dead space 0.07ml 0.07 ml 0.075ml 0.10ml

1262 Eysins,
Switzerland
bd.com
1.2 Certification
BD BD ISO CE MARKING BD
REFERENCE MANUFACTURER CERTIFICATION MANUFACTURING
SITE
307727, Becton Dickinson AENOR - EN ISO AEMPS N°0318 – Becton Dickinson S.A. -
307731, S.A. - Crta. 9001:2008 Certificate Certificate n Crta. Mequinenza, s/n.
307736, Mequinenza, s/n. Nº 2000 06 0272 CP 22520-Fraga (Huesca)
303221, 22520-Fraga (Huesca) N° ER-0097/1994 Spain
303139, Spain
303140, AEMPS NB nº0318
EN ISO 13485:2013
Certificate
N° 2015 05 0047EN
302986 Becton Dickinson DNV DNV 0434 – Becton Dickinson India
India (P) Ltd. EN ISO 9001:2008 Certificate n. (P) Ltd.
Plot No 1, Sector 3, Certificate 68879-2009-CE- Plot No 1, Sector 3,
IMT, Bawal-123 501, Nº150540-2014- IND-NA IMT, Bawal-123 501,
District Rewari, AQ-IND-NA District Rewari,
Haryana, India EN ISO 13485:2012 Haryana, India
Certificate Nº
150539-2014-AQ-
IND-NA
307728, Becton Dickinson AENOR - EN ISO AEMPS N°0318 – Becton Dickinson S.A. -
307740, S.A. - Crta. 9001:2008 Certificate Certificate Crta. Mequinenza, s/n.
307741, Mequinenza, s/n. Nº 95 06 0006 CP 22520-Fraga (Huesca)
307732, 22520-Fraga N° ER-0097/1994 Spain
307733, (Huesca) Spain
307735, AEMPS NB nº0318
307737, EN ISO 13485:2013
307738 Certificate
N° 2015 05 0047EN

1262 Eysins,
Switzerland
bd.com
1.3 Material
COMPONENT MATERIAL
Barrels, plunger rods POLYPROPYLENE
Barrels, Stoppers LATEX FREE ELASTOMER (TPE)
Barrels, Lubricant SILICONE OIL, <0.25 mg/cm2
NEEDLE
Needle Hub COLOR CODED POLYPROPYLENE
Needle Shield POLYPROPYLENE
Bonding Agent EPOXY
Needle STAINLESS STEEL AISI 304
(Chromium 18-20%; Nickel 8-12%; Manganese 2%; Silicon 1%)
Lubricant MEDICAL GRADE SILICONE, <0.25 mg/cm2
Web packaging POLYAMIDE

Box SOFT PAPER
1.4 Material of concern

Materials of concern are chemicals or substances that have been identified as having the potential
to cause long term effects on humans or the environment.
MATERIAL COMMENT
Phthalates The products do not contain phthalates.
No DEHP, CAS number 117-81-1, EC number 204-211-0, intentionally added
Latex The products do not contain natural latex.
Bisphenol A The products do not contain Bisphenol A.
Substances of animal The products were assessed for TSE (Transmissible Spongiform Encephalopathy)
origin BSE/TSE contamination risk. The raw materials used in the manufacture of this device do not
contain any animal tissue but may contain very small amounts of animal derived raw
materials. This product is manufactured using polymer resins which may contain very
small amounts of surfactants or fatty acids derived from tallow. Our resin suppliers have
confirmed that these tallow derived materials have been produced using multiple cycles of
conditions at least as rigorous (and normally more rigorous) as those specified in Annex
C.5 of EN ISO 22442-1. Therefore, the raw materials meet or exceed the requirements of
EN ISO 22442-1. Therefore, the raw materials do not to present any risk with respect to
TSE or other animal borne disease
Polyvinyl chloride (PVC) The products do not contain polyvinyl chloride
1.5 REACH information

BD maintains an active REACH compliance program and works closely with its supply base on
an ongoing basis with a view to obtaining information on REACH Substances of Very High
Concern (“SVHC”) through regular communication and exchange

1262 Eysins,
Switzerland
bd.com
1.6 Biocompatibility
BD Medical products comply with the requirements of the standard for biocompatibility of
medical devices, ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and
Testing.
1.7 Sterilization
Ethylene Oxide Sterilization following EN ISO 11135-1. ETO residues are within applicable
regulations.
1.8 Shelf life

Shelf life 5 years. No special storage or transportation condition. Recommendations are to store in
room temperature, in dry and warm place and not exposed to strong light.
1.9 Standards
Harmonised Standards Title
EN 556:2001+AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated
"STERILE".
EN 980:2008 Symbols for use in the labelling of medical devices
EN 1041:2008 Information supplied by the manufacturer with medical devices
EN 1422 :1997 + A1 :2009 Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test
methods
EN ISO 9001 :2008+AC :2009 Quality System Management. Requirements
EN ISO 10993 series Biological evaluation of medical devices
EN ISO 11135-1:2007 Sterilization of health-care products --.Ethylene oxide
EN ISO 11138:2009. Sterilization of health care products. Biological indicators.
EN ISO 11607 Packaging for terminally sterilized medical devices
 Part 1: 2009
 Part 2: 2006
EN ISO 11737 Sterilization of medical devices – Microbiological methods
EN ISO 13485:2012 / Medical devices - Quality management systems - Requirements for regulatory
AC:2012 purposes.
EN ISO 14971:2012 Medical devices. Application of risk management to medical devices.
EN 20594-1: 1993/ A1:1997 / Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical
AC:1996 equipment.

1262 Eysins,
Switzerland
bd.com
Non-Harmonised
Title
Standards
ISO 2859-1 :1999 + Cor.1 : Sampling procedures for Inspection by Attributes
2001 + Amd.1 :2011
EN ISO 6009 :1996 Sterile hypodermic needles for single use. Identification color coding
EN ISO 7864 : 1995 Sterile hypodermic needles for single use.
EN ISO 7886-1 :1997 Sterile hypodermic syringe for single use.

Part 1: Syringes for manual use.
EN ISO 9626:1995/A1:2002 Stainless steel needle tubing for the manufacture of medical devices.
EN ISO 15223-1:2012 Medical devices – Symbols to be used with medical device labels, labeling and
information to be supplied – Part 1: General requirements
EN ISO 14644-1:1999 Cleanrooms and associated controlled environments. Part 1: Classification of air
cleanliness
EN ISO 10993 series Biological evaluation of medical devices.
Part 10 : 2013. Tests for irritation and skin sensitization.
1.10 Classification
 BD Emerald™ with sterile needle, SKU 307728, 307740, 307741, 307732, 307733,
307735, 307737 and 307738, are classified as Medical Devices class IIa sterile with a
measuring function classification rule 6 according to Medical Devices Directive
93/42/EEC.
 BD Emerald™ with blunt fill needle, SKU 303221, 303139 and 303140, are classified as
Medical Devices class I sterile with a measuring function, classification rule 2 according
to Medical Devices Directive 93/42/EEC.
 BD Emerald™ without needle, SKU 307727, 307731, 307736 and 302986, are classified
as Medical Devices class I sterile with a measuring function, classification rule 2
according to Medical Devices Directive 93/42/EEC.
1.11 GMDN code

GMDN code 47017: General purpose syringes.

1262 Eysins,
Switzerland
bd.com
1.12 Good Manufacturing practices

The entire manufacturing and testing processes are following the Good Manufacturing Practices
as specified below
 Incoming raw materials are verified via material inspection and testing and our suppliers
are approved via our vendor management system.
 In addition to the automatic on-line inspections, in-process inspections are performed in
addition to final product testing to ensure compliance with approved specifications.
 The manufacturing and testing details of each batch of product are recorded on a batch
record which is retained in accordance with our document control procedures
 BD operates a system of Internal and external audits to maintain compliance
 BD confirms that it will continue to adhere to relevant international standards in designing
and manufacturing its products.
 BD reserves the right to use the internal change control procedure to change raw material
suppliers and production process
1.13 Others
 (Material) Safety Data Sheets are not required for this product
 Certificate of Food Contact (COMMISSION REGULATION (EU) No. 10/2011 of January
14th, 2011 concerning materials and plastic objects intended to get in touch with
foodstuffs) is not required as BD products are used for general purpose injection and
aspiration of fluids from vials, ampoules and parts of the body below the surface of the
skin.
 The EU representative for India produced syringe catalogue number 302986 is BD Temse,
Belgium. Other syringes are produced by a European manufacturer.
2. Packaging
2.1 Packaging material

LABELS: according to European Medical Device directive, multilingual

1262 Eysins,
Switzerland
bd.com
2.2 Example labeling

Unit pack label, Syringe only, from document DGW1044
Unit pack label, Syringe with pre-attached needle, from document DGW1044
Unit pack label, Syringe with Blunt fill needle, from document 10000212108


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Interlink® System and BD™

BD Safety-Lok™ Syringes (sterile, single use)

1 mL BD Safety-Lok™ Insulin Syringe

Self-Contained Package. 200 per box, 200 per case

329465 28 G x 1/2 in. U-100 BD Micro-Fine™ IV (Orange)

Self-Contained Package. 200 per box, 200 per case

329465 28 G x 1/2 in. U-100 BD Micro-Fine™ IV (Orange)

Self-Contained Package. 200 per box, 200 per case

329465 28 G x 1/2 in. U-100 BD Micro-Fine™ IV (Orange)

Self-Contained Package. 200 per box, 200 per case

329465 28 G x 1/2 in. U-100 BD Micro-Fine™ IV (Orange)

Self-Contained Package. 200 per box, 200 per case

329465 28 G x 1/2 in. U-100 BD Micro-Fine™ IV (Orange)

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1 mL BD Safety-Lok™ Insulin Syringe

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1 mL BD Safety-Lok™ Insulin Syringe

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1 mL BD Safety-Lok™ Insulin Syringe

BD Safety-Lok™ Syringes (sterile, single use)

1 mL BD Safety-Lok™ Insulin Syringe

Dear Meriam Youssef:

U.S. Food & Drug Administration

DHT3C: Division of Drug Delivery and

Submitted By: Meriam Youssef

Date Prepared: September 19, 2019

Device Name: Trade Name: BD Insulin Syringe™

Legally marketed predicate device to which substantial equivalence is being claimed:

Substantial Equivalence Discussion:

Polypropylene Polypropylene New material

Legal Manufacturer: Becton, Dickinson and Company Limited,

Becton Dickinson S.A.

Date: 04 November 2019

Name Andrew Roche

BD Microlance 3 Revision Number: 09

Directors: C. Reynolds, P. Keenan, D. Hopkin (UK)

Directors: C. Reynolds, P. Keenan, D. Hopkin (UK)

BD Microlance 3 Revision Number: 09

Directors: C. Reynolds, P. Keenan, D. Hopkin (UK)

Directors: C. Reynolds, P. Keenan, D. Hopkin (UK)

NON-STERILE NEEDLES (BULK)

BD Microlance 3 Revision Number: 09

Directors: C. Reynolds, P. Keenan, D. Hopkin (UK)

Directors: C. Reynolds, P. Keenan, D. Hopkin (UK)

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Bevel-up needle orientation for

BD SafetyGlide™ Needles 3 mL Syringes with BD SafetyGlide™ Needles

1 mL Syringes with BD SafetyGlide™ Needles 305907 22 GA x 1 1/2 in. 50 Box, 400/Case

PROD # Description Packaging

Needles and Syringes

for Insulin, TB or Allergy

Permanently Rotation of safety Clear scale

Needle tip is Safety arm can be

BD SafetyGlide Needles with

(RB) = Regular bevel

Needles and Syringes

Red area = waste space

The BD Integra Syringe has up to

• The clinician decides when to activate the retracting mechanism either

Visit www.bd.com/Integra for more information.

Needles and Syringes

With Retracting BD PrecisionGlide™ Needle

 eedle Retracts into the Syringe!

BD Integra™ 3 mL Syringe Only

• The clinician decides when to activate the retracting mechanism either

eedle Retracts into the Syringe!