Establishment Registration & Device Listing https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=7...

FDA Home3 Medical Devices4 Databases5

Establishment Registration & Device Listing
New Search Back To Search Results
Proprietary Scientific Freezer BT-1200/10; Scientific Freezer BT-1200/1000;
Name: Scientific Freezer BT-1200/140; Scientific Freezer
BT-1200/1500; Scientific Freezer BT-1200/20; Scientific Freezer
BT-1200/300; Scientific Freezer BT-1200/420; Scientific Freezer
BT-1200/50; Scientific Freezer BT-1200/560; Scientific Freezer
BT-1200/80; Scientific Freezer BT-1300/1200; Scientific Freezer
BT-1300/140; Scientific Freezer BT-1300/1500; Scientific
Freezer BT-1300/1700; Scientific Freezer BT-1300/260;
Scientific Freezer BT-1300/335; Scientific Freezer BT-1300/520;
Scientific Refrigerator BT-1100/10; Scientific Refrigerator
BT-1100/100; Scientific Refrigerator BT-1100/1000; Scientific
Refrigerator BT-1100/120; Scientific Refrigerator BT-1100/1200;
Scientific Refrigerator BT-1100/1350; Scientific Refrigerator
BT-1100/140; Scientific Refrigerator BT-1100/1500; Scientific
Refrigerator BT-1100/1700; Scientific Refrigerator BT-1100/20;
Scientific Refrigerator BT-1100/240; Scientific Refrigerator
BT-1100/260; Scientific Refrigerator BT-1100/280; Scientific
Refrigerator BT-1100/300; Scientific Refrigerator BT-1100/340;
Scientific Refrigerator BT-1100/350; Scientific Refrigerator
BT-1100/360; Scientific Refrigerator BT-1100/400; Scientific
Refrigerator BT-1100/420; Scientific Refrigerator BT-1100/50;
Scientific Refrigerator BT-1100/500; Scientific Refrigerator
BT-1100/560; Scientific Refrigerator BT-1100/600; Scientific
Refrigerator BT-1100/700; Scientific Refrigerator BT-1100/80;
Scientific Refrigerator BT-1100/800; Scientific Refrigerator
BT-1100/900
Classification
REFRIGERATOR, FREEZER, BLOOD STORAGE
Name:
Product Code: KSE6
Device Class: 2
Regulation
Number: 864.97007
Medical
Hematology
Specialty:
Registered
Establishment BIOTECNO INDUSTRIA E COMERCIO LTDA8
Name:
Registered
Establishment 3017882410
Number:
Owner/Operator: BIOTECNO INDUSTRIA E COMERCIO LTDA9
Owner/Operator
10079980
Number:
Establishment
Manufacturer
Operations:

Links on this page:

1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
2. http://www.addthis.com/bookmark.php
3. https://www.fda.gov/
4. https://www.fda.gov/Medical-Devices
5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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Establishment Registration & Device Listing https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=7...

assistance/medical-device-databases
6. /scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2478
7. /scripts/cdrh/cfdocs/cfCFR/CFRsearch.cfm?FR=864.9700
8. /scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=286173
9. /scripts/cdrh/cfdocs/cfRL/rl.cfm?start_search=1&OwnerOperatorNumber=10079980

Page Last Updated: 11/22/2021

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Links on this page:

1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
2. http://www.addthis.com/bookmark.php
3. https://www.fda.gov/
4. https://www.fda.gov/Medical-Devices
5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/medical-device-databases
6. /scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2478
7. /scripts/cdrh/cfdocs/cfCFR/CFRsearch.cfm?FR=864.9700
8. /scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=286173
9. /scripts/cdrh/cfdocs/cfRL/rl.cfm?start_search=1&OwnerOperatorNumber=10079980

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