Identity
- Trade Name
- BiCart FDA UDI
- Generic Name
- Haemodialysis concentrate FDA UDI
- Device Name
- Sodium Bicarbonate for Hemodialysis FDA UDI
- Model / Reference
- 1250 FDA UDI
- Description
- Sodium Bicarbonate for Hemodialysis FDA UDI
Identifiers
- Catalog Number
- 114014 FDA UDI
- Primary DI / UDI-DI
- 07332414110574 FDA UDI
- 510(k) Number
- K013724 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
No
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
Dimensions & Sizes
- Size
- Weight — 1250 Gram FDA UDI
Category: Haemodialysis concentrate
BiCart by Vantive Health GmbH — Class II — FDA UDI — listed in FDA GUDID — 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
K013724 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vantive Health GmbH
Sources (1)
- FDA UDI 0e453fa1-e69b-4d9d-9f0b-7f4f9ed7fcda 38 fields · synced May 31, 2026