Identity
- Trade Name
- PrismaSATE FDA UDI
- Generic Name
- Haemodialysis dialysate solution FDA UDI
- Device Name
- The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances. FDA UDI
- Model / Reference
- 105351 FDA UDI
- Description
- The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances. FDA UDI
Identifiers
- Catalog Number
- 105351S FDA UDI
- Primary DI / UDI-DI
- 07332414037048 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
No
FDA UDI
Category: Haemodialysis dialysate solution
PrismaSATE by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis dialysate solution.
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- NxStage PureFlow Solution — NxStage Medical, Inc. · Class II
- NxStage PureFlow B Solution — NxStage Medical, Inc. · Class II
- PRISMASATE — Baxter Healthcare Corp · Class II
- Bicarby — Fresenius Medical Care Renal Therapies Group, LLC · Class II
- NxStage PureFlow Solution — NxStage Medical, Inc. · 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
- Baxter International Inc.
Sources (1)
- FDA UDI 60002b9c-2e5d-42a5-a367-702e99e6b89a 36 fields · synced May 30, 2026