Identity
- Trade Name
- Polyflux FDA UDI
- Generic Name
- Hollow-fibre haemodialysis dialyser, single-use FDA UDI
- Device Name
- the Polyflux 6H is intended for chronic and acute applications in haemodialysis haemofiltration and hemofiltration on small patient including pediatric indication, considering blood flow, body weight and extracoporeal blood volume FDA UDI
- Model / Reference
- 6H FDA UDI
- Description
- the Polyflux 6H is intended for chronic and acute applications in haemodialysis haemofiltration and hemofiltration on small patient including pediatric indication, considering blood flow, body weight and extracoporeal blood volume FDA UDI
Identifiers
- Catalog Number
- 103403 FDA UDI
- Primary DI / UDI-DI
- 07332414036386 FDA UDI
- 510(k) Number
- K051520 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Hollow-fibre haemodialysis dialyser, single-use 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: Hollow-fibre haemodialysis dialyser, single-use
Polyflux by Gambro Dialysatoren GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 2ad7f543-3d3e-48f9-bb2f-21eb86cc7494 37 fields · synced May 30, 2026