Identity
- Trade Name
- DIASOL FDA UDI
- Generic Name
- Haemodialysis concentrate FDA UDI
- Device Name
- Diasol Liquid Acid Concentrate for Bicarbonate Dialysis FDA UDI
- Model / Reference
- 1001225-75200 FDA UDI
- Description
- Diasol Liquid Acid Concentrate for Bicarbonate Dialysis FDA UDI
Identifiers
- Catalog Number
- ACD2-ACG8 FDA UDI
- Primary DI / UDI-DI
- B467100122575200 FDA UDI
- 510(k) Number
- K851431 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
Yes
FDA UDI
Category: Haemodialysis concentrate
Diasol by Diasol Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis concentrate.
- 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
- RenalPure — Rockwell Medical · Class II
- Centrisol Acid Concentrate — MEDIVATORS INC. · Class II
Cleared under the same submission
K851431 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
- Diasol Inc
Sources (1)
- FDA UDI 09c38ab6-3d8e-4bc7-9ea5-8ba0eacc4e34 37 fields · synced May 31, 2026