Identity
- Trade Name
- ACCUSOL Dialysis Solution for CRRT FDA UDI
- Generic Name
- Haemodialysis concentrate FDA UDI
- Device Name
- Accusol 35 0K+ 0 DEX Solution is indicated for use as dialysis solutions in Continuous Renal Replacement Therapy. FDA UDI
- Model / Reference
- 35 0K+ 0DEX FDA UDI
- Description
- Accusol 35 0K+ 0 DEX Solution is indicated for use as dialysis solutions in Continuous Renal Replacement Therapy. FDA UDI
Identifiers
- Catalog Number
- 5B9250 FDA UDI
- Primary DI / UDI-DI
- 00085412079134 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
- Not 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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2500 Milliliter FDA UDI
ACCUSOL Dialysis Solution for CRRT by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Baxter International Inc.
Sources (1)
- FDA UDI a8ecde9d-003e-4b55-a35c-f1fb013ac200 38 fields · synced May 30, 2026