Identity
- Trade Name
- O-Wrap™ Bag EUDAMEDO-Wrap FDA UDI
- Generic Name
- Blood/tissue storage/culture container FDA UDI
- Device Name
- OW2436 EUDAMEDO-Wrap, overwrap pouch for freezing, 24x36cm FDA UDI
- Model / Reference
- OW2436 EUDAMEDFDA UDI
- Description
- O-Wrap, overwrap pouch for freezing, 24x36cm FDA UDI
Identifiers
- Catalog Number
- OW2436 FDA UDI
- Primary DI / UDI-DI
- 10816203022254 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10816203022254 EUDAMED
- FDA Product Code
- FMH FDA UDI
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
- GMDN Term
- Blood/tissue storage/culture container FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
O-Wrap™ Bag by OriGen Biomedical, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10816203022254 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- OriGen Biomedical Inc.
- EUDAMED SRN
- US-MF-000018098
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 6a447983-b8b2-4559-8adb-5730b481d96d 61 fields · synced Jun 18, 2026
- FDA UDI c128e586-7ed4-4455-b825-6ffd949c782a 36 fields · synced May 30, 2026