Identity
- Trade Name
- Centrisol Acid Concentrate FDA UDI
- Generic Name
- Haemodialysis concentrate FDA UDI
- Model / Reference
- SB-351 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00677964044304 FDA UDI
- FDA Product Code
- FKQ 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haemodialysis concentrate
Centrisol Acid Concentrate by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis concentrate.
- DIASOL — DIASOL INC · Class II
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- 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
- DIASOL — DIASOL INC · Class II
- RenalPure — Rockwell Medical · Class II
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
- Medivators Inc.
Sources (1)
- FDA UDI b53e4265-7832-46b8-9997-518e48ac3c5a 32 fields · synced May 30, 2026