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Traceability Labels for cryopreservation
FDA UDIClass II (US FDA UDI)
by Biosafe S.A.
Identity
- Trade Name
- Traceability Labels for cryopreservation FDA UDI
- Generic Name
- Blood centrifugation system containment kit FDA UDI
- Model / Reference
- Traceability Labels for cryopreservation FDA UDI
Identifiers
- Catalog Number
- 7011 FDA UDI
- Primary DI / UDI-DI
- 07640125650495 FDA UDI
- FDA Product Code
- OAO FDA UDI
- GMDN Term
- Blood centrifugation system containment kit 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Traceability Labels for cryopreservation 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 |
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Manufacturer
- Manufacturer
- Biosafe S.A.
Sources (1)
- FDA UDI 70af8243-c130-44b0-8cf2-13cbc13867e1 36 fields · synced May 31, 2026