Duns Number:120664557
Device Description: Intended Use: The EndoPur Endotoxin 10” Filter Fin is a hollow fiber ultrafilter that reta Intended Use: The EndoPur Endotoxin 10” Filter Fin is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 10” Filter Fin is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
Catalog Number
-
Brand Name
EndoPur Endotoxin 10" Filter Fin
Version/Model Number
70-0110F
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 18, 2017
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
-
Product Code
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
23021270-501f-4125-a6a0-b408e783d03a
Public Version Date
September 17, 2021
Public Version Number
4
DI Record Publish Date
September 29, 2017
Package DI Number
20866318000361
Quantity per Package
30
Contains DI Package
10866318000364
Package Discontinue Date
December 18, 2017
Package Status
Not in Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |