Identity
- Trade Name
- Polyflux FDA UDI
- Generic Name
- Hollow-fibre haemodialysis dialyser, single-use FDA UDI
- Device Name
- The Polyflux 21L is intended for use in haemodialysis for the treatment of chronic or acute renal failure FDA UDI
- Model / Reference
- 21L FDA UDI
- Description
- The Polyflux 21L is intended for use in haemodialysis for the treatment of chronic or acute renal failure FDA UDI
Identifiers
- Catalog Number
- 104176 FDA UDI
- Primary DI / UDI-DI
- 07332414048181 FDA UDI
- FDA Product Code
- FJI FDA UDI
- GMDN Term
- Hollow-fibre haemodialysis dialyser, single-use 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 2.1 Square meter FDA UDI
Category: Hollow-fibre haemodialysis dialyser, single-use
Polyflux by Gambro Dialysatoren GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hollow-fibre haemodialysis dialyser, single-use.
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- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- NIPRO ELISIO™ -M HEMODIALYZER — NIPRO MEDICAL CORPORATION · Class II
- FX CorAL 60 Dialyzer — Fresenius Medical Care Holdings, Inc. · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- Optiflux® — Fresenius Medical Care Holdings, 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
- Gambro Dialysatoren GmbH
Sources (1)
- FDA UDI bb5f947c-b7ca-46e1-a83f-3d6cff1d6db8 37 fields · synced May 29, 2026