Identity
- Trade Name
- B.BRAUN FDA UDI
- Generic Name
- Apheresis kit FDA UDI
- Device Name
- H.E.L.P. Heparin Sodium Solution 30 mL FDA UDI
- Model / Reference
- 7061188 FDA UDI
- Description
- H.E.L.P. Heparin Sodium Solution 30 mL FDA UDI
Identifiers
- Catalog Number
- 7061188 FDA UDI
- Primary DI / UDI-DI
- 04046964319860 FDA UDI
- FDA Product Code
- MMY FDA UDI
- GMDN Term
- Apheresis kit FDA UDI
Classification
- Device Class
- Class III 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
B.braun by B.Braun Avitum AG — Class III — 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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B.Braun Avitum AG
Sources (1)
- FDA UDI 2deb3915-6b22-492c-951c-4955831f6f61 38 fields · synced May 30, 2026