Duns Number:316150549
Device Description: The U9000 Plus Ultrafilter is indicated for purification of incoming water for dialysis fl 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.
Catalog Number
955825
Brand Name
U9000 Plus ultrafilter
Version/Model Number
955825
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K211035,K211035
Product Code
FIP
Product Code Name
Subsystem, water purification
Public Device Record Key
1ca0fb18-4b8b-491a-a0e2-604f19b9fb6d
Public Version Date
January 07, 2022
Public Version Number
1
DI Record Publish Date
December 30, 2021
Package DI Number
37332414126958
Quantity per Package
16
Contains DI Package
07332414126957
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |