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U9000 Plus ultrafilter

FDA UDI

Class II (US FDA UDI)

by Gambro Dialysatoren GmbH

Identity

Trade Name
U9000 Plus ultrafilter FDA UDI
Generic Name
Microbial water purification filter, sterilizable FDA UDI
Device Name
The U9000 Plus Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized. FDA UDI
Model / Reference
955825 FDA UDI
Description
The U9000 Plus Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized. FDA UDI

Identifiers

Catalog Number
955825 FDA UDI
Primary DI / UDI-DI
07332414126957 FDA UDI
FDA Product Code
FIP FDA UDI
GMDN Term
Microbial water purification filter, sterilizable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5665 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Category: Microbial water purification filter, sterilizable

U9000 Plus ultrafilter by Gambro Dialysatoren GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microbial water purification filter, sterilizable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gambro Dialysatoren GmbH

Sources (1)

  • FDA UDI 1ca0fb18-4b8b-491a-a0e2-604f19b9fb6d 35 fields · synced May 30, 2026