Duns Number:316150549
Device Description: The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient
Catalog Number
104333
Brand Name
POLYFLUX
Version/Model Number
8LR
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 09, 2021
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
K043342,K043342
Product Code
FJI
Product Code Name
DIALYZER, CAPILLARY, HOLLOW FIBER
Public Device Record Key
35a91a5b-3a97-453b-85bd-824216dc13ee
Public Version Date
September 23, 2021
Public Version Number
5
DI Record Publish Date
October 12, 2015
Package DI Number
37332414041473
Quantity per Package
16
Contains DI Package
07332414041472
Package Discontinue Date
April 09, 2021
Package Status
Not 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 |