Duns Number:692097404
Device Description: Intended for use in hemodialysis for the treatment of patients suffering from acute or chr Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.
Catalog Number
-
Brand Name
REXEED
Version/Model Number
21S
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
-
Product Code
KDI
Product Code Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Public Device Record Key
a2741849-0948-47eb-b3e0-60a1a35806af
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
November 01, 2015
Package DI Number
14537693003917
Quantity per Package
12
Contains DI Package
04537693003910
Package Discontinue Date
-
Package Status
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. | 3 |