Identity
- Trade Name
- PermaLife FDA UDI
- Generic Name
- Blood/tissue storage/culture container FDA UDI
- Device Name
- 325ml Cell Culture bag, FEP, 4th Generation FDA UDI
- Model / Reference
- PL325-4G FDA UDI
- Description
- 325ml Cell Culture bag, FEP, 4th Generation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816203021820 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 by OriGen Biomedical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood/tissue storage/culture container.
- Corning — CORNING INCORPORATED · Class I
- Corning — CORNING INCORPORATED · Class I
- Corning — CORNING INCORPORATED · Class I
- Corning — CORNING INCORPORATED · Class I
- Corning — CORNING INCORPORATED · Class I
- Corning — CORNING INCORPORATED · Class I
- Corning — CORNING INCORPORATED · Class I
- Corning — CORNING INCORPORATED · Class I
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 c3f43766-605b-478d-a25a-8c1842ea69f7 34 fields · synced May 30, 2026