Duns Number:958291411
Device Description: F160 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.4 m2 / Ebeam / Single Use / 77 F160 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.4 m2 / Ebeam / Single Use / 77 mL
Catalog Number
-
Brand Name
Optiflux® Ultra
Version/Model Number
0500416E
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2015
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
KDI
Product Code Name
Dialyzer, high permeability with or without sealed dialysate system
Public Device Record Key
d9abd854-68a1-417f-b66d-9cc9049ff24e
Public Version Date
May 05, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
10840861100184
Quantity per Package
12
Contains DI Package
00840861100187
Package Discontinue Date
September 24, 2015
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |