Identity
- Trade Name
- Bicarby FDA UDI
- Generic Name
- Haemodialysis dialysate solution FDA UDI
- Device Name
- Bicarby Dialysate RFP-407 FDA UDI
- Model / Reference
- RFP-407-G FDA UDI
- Description
- Bicarby Dialysate RFP-407 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840861102846 FDA UDI
- FDA Product Code
- KPO FDA UDI
- GMDN Term
- Haemodialysis dialysate solution 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5000 Milliliter FDA UDI
Category: Haemodialysis dialysate solution
Bicarby by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PRISMASATE — Baxter Healthcare Corp · Class II
- NxStage PureFlow Solution — NxStage Medical, Inc. · Class II
Cleared under the same submission
K233950 also covers:
K243786 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 |
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Manufacturer
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
Sources (1)
- FDA UDI d0e5b175-8bef-4a7c-acce-8736195d7e24 36 fields · synced Jun 8, 2026