Identity
- Trade Name
- PermaLife™ Cell Culture Bag FDA UDI
- Generic Name
- Blood/tissue storage/culture container FDA UDI
- Device Name
- PermaLife Cell Culture Bag, 30 mL with 10cm sheath FDA UDI
- Model / Reference
- PL30M FDA UDI
- Description
- PermaLife Cell Culture Bag, 30 mL with 10cm sheath FDA UDI
Identifiers
- Catalog Number
- PL30M FDA UDI
- Primary DI / UDI-DI
- 10816203024104 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
- 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
Category: Blood/tissue storage/culture container
PermaLife™ Cell Culture Bag by OriGen Biomedical, Inc. — Class U — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- OriGen Biomedical, Inc.
Sources (2)
- FDA UDI fa3668dd-212e-4e3a-a756-83b443425a60 37 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026