Identity
- Trade Name
- ALLKARE FDA UDI
- Generic Name
- Synthetic-polymer liquid barrier dressing FDA UDI
- Device Name
- Allkare® Protective Barrier Wipe - 50 Pack FDA UDI
- Model / Reference
- 037439 FDA UDI
- Description
- Allkare® Protective Barrier Wipe - 50 Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455107667 FDA UDI
- FDA Product Code
- EXE FDA UDI
- GMDN Term
- Synthetic-polymer liquid barrier dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5900 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
No
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
Allkare by Convatec, Purchasing Department — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Convatec, Purchasing Department
Sources (1)
- FDA UDI 6d3c7d48-494e-4b01-bacf-0a9b3bbf725b 35 fields · synced May 29, 2026