Identity
- Trade Name
- B.BRAUN FDA UDI
- Generic Name
- Device-irrigation sterile saline solution FDA UDI
- Device Name
- HELP 0,9 % SODIUM CHL. SET US 500/1500ML FDA UDI
- Model / Reference
- 4103 FDA UDI
- Description
- HELP 0,9 % SODIUM CHL. SET US 500/1500ML FDA UDI
Identifiers
- Catalog Number
- 4103 FDA UDI
- Primary DI / UDI-DI
- 04046964290138 FDA UDI
- FDA Product Code
- MMY FDA UDI
- GMDN Term
- Device-irrigation sterile saline solution 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
Yes
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 |
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Manufacturer
- Manufacturer
- B.Braun Avitum AG
Sources (1)
- FDA UDI a3138d1c-0a62-4f32-aa57-2a7c1b664bd1 38 fields · synced Jun 8, 2026