Identity
- Trade Name
- CryoSC-D Freezing Bag FDA UDI
- Generic Name
- Blood/tissue storage/culture container FDA UDI
- Model / Reference
- FB-100.2 FDA UDI
Identifiers
- Catalog Number
- 10032 FDA UDI
- Primary DI / UDI-DI
- 07640125650389 FDA UDI
- FDA Product Code
- OOF FDA UDI
- GMDN Term
- Blood/tissue storage/culture container FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9900 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
CryoSC-D Freezing Bag by Biosafe S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
BK090037 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosafe S.A.
Sources (1)
- FDA UDI 113c7bfe-320a-4135-8c81-fd2b77f20faa 36 fields · synced Jun 8, 2026