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
- 21R 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
- 100691 FDA UDI
- Primary DI / UDI-DI
- 07332414031787 FDA UDI
- FDA Product Code
- KDI FDA UDIMSF 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 c8fea08e-b30e-48d2-a202-5eac3e12b0d9 37 fields · synced May 30, 2026