Identity
- Trade Name
- POLYFLUX FDA UDI
- Generic Name
- Hollow-fibre haemodialysis dialyser, reusable FDA UDI
- Device Name
- Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocessed for reuse on the same patient FDA UDI
- Model / Reference
- 24R FDA UDI
- Description
- Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocessed for reuse on the same patient FDA UDI
Identifiers
- Catalog Number
- 104324 FDA UDI
- Primary DI / UDI-DI
- 07332414036140 FDA UDI
- FDA Product Code
- FJI FDA UDIMSF FDA UDIKDI FDA UDI
- GMDN Term
- Hollow-fibre haemodialysis dialyser, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI876.5860 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Polyflux by Gambro Dialysatoren GmbH — 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
- Gambro Dialysatoren GmbH
Sources (1)
- FDA UDI 5092af02-da21-44da-a799-11f1a96df9c9 37 fields · synced May 30, 2026