Duns Number:343689704
Device Description: XEVONTA DIALYZER HI 12 US, GAMMA
Catalog Number
7204401
Brand Name
xevonta
Version/Model Number
7204401
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 09, 2019
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
fabd35b5-b04b-49aa-8cc5-243bc6eee1ee
Public Version Date
August 20, 2021
Public Version Number
5
DI Record Publish Date
August 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 69 |
| 3 | A medical device with high risk that requires premarket approval | 1 |