Identity
- Trade Name
- PRISMAFLEX SET FDA UDI
- Generic Name
- Haemofilter FDA UDI
- Device Name
- The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. FDA UDI
- Model / Reference
- HF1400 FDA UDI
- Description
- The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. FDA UDI
Identifiers
- Catalog Number
- 107142 FDA UDI
- Primary DI / UDI-DI
- 07332414069315 FDA UDI
- 510(k) Number
- K042938 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Haemofilter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 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
Category: Haemofilter
Prismaflex Set by Gambro Industries — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042938 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
- Gambro Industries
Sources (1)
- FDA UDI 8df110ab-8a7f-444e-ba68-c8ecf3636437 37 fields · synced Jun 7, 2026