Identity
- Trade Name
- POLYFLUX FDA UDI
- Generic Name
- Hollow-fibre haemodialysis dialyser, reusable FDA UDI
- Device Name
- The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient FDA UDI
- Model / Reference
- 8LR FDA UDI
- Description
- The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient FDA UDI
Identifiers
- Catalog Number
- 104333 FDA UDI
- Primary DI / UDI-DI
- 07332414041472 FDA UDI
- FDA Product Code
- MSF FDA UDIKDI FDA UDIFJI FDA UDI
- GMDN Term
- Hollow-fibre haemodialysis dialyser, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 FDA UDI876.5820 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 35a91a5b-3a97-453b-85bd-824216dc13ee 37 fields · synced May 30, 2026