Dynarex Corporation 10 Gienshaw Street Orangeburg, NY 10962 TECHNICAL SPECIFICATION Ts# MM226-ZMCHO2 Rev: Initial Issue Date Issued: 01/25/10 Dynarex Corporation Technical Specification Document Number: MM228-ZMCHO2. Originator Approved By: Date UNCONTROLLED COPY QA Department Head Date Manufacturer Representative Date Revision History (Bate Ree TONEY 5 ‘Reason for Change 1/25/10 oO MA Initial Issue Page 1 of 4Dynarex Corporation 40 Glenshaw Street (Orangeburg, NY 10962 Title Manufacturer Reorder Number Restrictions Description Device Class TECHNICAL SPECIFICATION TS #: MM228-ZMCH2_" Rev: inital lssue Date Issued: 01/25/2010 UNCONTROLLED Copy Technical Specification 4271 Urinary Drainage Bag, St.2000 ml Bag-20/Cs 4270 Urinary Drainage Bag, St.2000 ml Bag-20/Cs 4281 Urinary Leg Bag, Med 600 ml, Twist Valve, St-4/12/Cs 4282 Urinary Leg Bag, Med 1000 mi, Twist Valve, St-4/12/Cs 4270, 4271, 4281, 4282 No changes may be made to the manufacturing Process or any materials without written permission from Dynarex Corp. QA Department. 4270-2000ml Urinary Drainage Bag 4271-2000mi Urinary Drainage Bag 4281-600m! Urinary Leg Bag 4282-1000mI Urinary Leg Bag Is 1.0 Component Descriptions #4270 tea 2000ml Bag Body Pvc 1ea Protection Cap PE tea _Needieless Sampling Port PVCITPE tea 40mmx1070mm Inlet Tubing Pvc jea Hanger PP tea Non-return Valve Pvc tea Air Vent PA jea Outlet Tubing pyc tea T-tap with White Plug PPIPE #0271 tea 2000mi Bag Body Pvc 4ea Protection Cap PE tea Needleless Sampling Port PYCITPE 4ea 10mmx1100mm Star Inlet Tubing PVC tea Bed Sheet Clamp ABS 4ea Hanger PP Page 2 of 4UNCONTROLLED COPY Dynarex Corporation 10 Glenshaw Street Orangobura, NY 10962 TECHNICAL SPECIFICATION TS ff; MM228-2MCH2 ” Rev: Initial Issue Date Issued: 01/25/2010 tea White Tie NYLON ea Drip Chamber with Non-return Valve PVC tea Air Vent PA Yea Outlet Tubing pve tea T-tap with White Plug PPIPE tea Nipple Pv #4281 tea 600ml Bag Body Pvc jea Protection Cap PE tea Standard Connector PP tea Non-return Valve Pvc tea Twist Viave PPIPE 2ea Straps 2ea Button ABS #4282 ‘tea 100ml Bag Body pvc tea Protection Cap PE jea Standard Connector PP tea Non-return Valve Pvc tea Twist Valve PPIPE 2ea Straps 2ea__ Button ABS 2.0 Product Dimensions (Inches) Reorder Length Width am | 2 11.2 4271 17 10.7 | 4281 99 47 4282 19 | 52 3.0 Packagins 3.1 Master Carton ae <=Dynarex Corporation TECHNICAL SPECIFICATION 10 Glenshaw Street TS Hf: MM226-ZMCH2 "Rev: Initial issue Orangeburg, NY 10962 Date Issued: 01/25/2010 UNCONTROLLED Copy Reorder # ‘Case count | Length (inches) | Height (inches) | Width (inches) | 4270 _20 42.8 8.4 Sony Bi 4271 20 14.6 118 7.9 4281 48 18 10.6 a3 4282 48 16 18 79 Tolerances: Alldimensions +/- 4/16 inch 4.0 Labeling ‘As per approved artwork by Dynarex. 4.1 Lot Numbering Lot numbering will be 5 digit purchase order issued by Dynarex Corporation. 5.0 Testing Per final inspection criteria of Urine Drainage Bag on QA department. 6.0 Sterilization: Sterilization to be performed in accordance with ANSVAAMMISO 11135-19948ISO 11135- 2007 by 100% ethylene oxide/nitrogen (EOIN2) process. END Page 4 of 4