Identity
- Trade Name
- Sol-Cart B® FDA UDI
- Generic Name
- Haemodialysis concentrate FDA UDI
- Device Name
- Solcart B® Bicarbonate Cartridge 760 grams FDA UDI
- Model / Reference
- 803 FDA UDI
- Description
- Solcart B® Bicarbonate Cartridge 760 grams FDA UDI
Identifiers
- Catalog Number
- 803 FDA UDI
- Primary DI / UDI-DI
- 04046963332730 FDA UDI
- 510(k) Number
- K072760 FDA UDI
- FDA Product Code
- KPO FDA UDI
- GMDN Term
- Haemodialysis concentrate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- 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
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: Haemodialysis concentrate
Sol-Cart B® by B.Braun Avitum AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis concentrate.
- DIASOL — DIASOL INC · Class II
- CitraPure — Rockwell Medical · Class II
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC. · Class II
- Di-Chem Hemodialysate Additive — Di-Chem, Incorporated · Class II
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC. · Class II
- CitraPure — Rockwell Medical · Class II
- Centrisol Acid Concentrate — MEDIVATORS INC. · Class II
- DIASOL — DIASOL INC · Class II
Cleared under the same submission
K072760 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- B.Braun Avitum AG
Sources (2)
- FDA UDI acae7d75-a0bf-4d83-84d9-7851d4b803c7 38 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 29, 2026