Duns Number:316150549
Device Description: The Polyflux 14L capillary dialyzer is intended for use in haemodialysis for the treatment The Polyflux 14L capillary dialyzer is intended for use in haemodialysis for the treatment of chronic and acute renal failure.
Catalog Number
102057
Brand Name
Polyflux
Version/Model Number
14L
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
Yes
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
ed5a44f3-6177-414d-aa90-4b7268ef4444
Public Version Date
October 11, 2022
Public Version Number
6
DI Record Publish Date
October 12, 2015
Package DI Number
37332414036424
Quantity per Package
24
Contains DI Package
07332414036423
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 |