Identity
- Trade Name
- Cryobag FDA UDI
- Generic Name
- Blood/tissue storage/culture container FDA UDI
- Device Name
- Cryobag, 14 x 20, Kapton/FEP FDA UDI
- Model / Reference
- CB1420 FDA UDI
- Description
- Cryobag, 14 x 20, Kapton/FEP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816203020687 FDA UDI
- 510(k) Number
- K021702 FDA UDI
- FDA Product Code
- LPZ FDA UDI
- GMDN Term
- Blood/tissue storage/culture container FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Cryobag by OriGen Biomedical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K021702 also covers:
- PermaLife — OriGen Biomedical, Inc.
- PermaLife™ Cell Culture Bag — OriGen Biomedical, Inc.
- PermaLife™ Cell Culture Bag — OriGen Biomedical, Inc.
- PermaLife™ Cell Culture Bag — OriGen Biomedical, Inc.
- PermaLife™ Cell Culture Bag — OriGen Biomedical, Inc.
- PermaLife™ Cell Culture Bag — OriGen Biomedical, Inc.
- PermaLife™ Cell Culture Bag — OriGen Biomedical, Inc.
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OriGen Biomedical, Inc.
Sources (1)
- FDA UDI 87158162-8a2b-4723-85fa-083b2c644a1c 36 fields · synced Jun 8, 2026