Duns Number:489176113
Device Description: The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenate The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machineperfusion of kidneys for the preservation, transport, and eventual transplantation into a recipient.
Catalog Number
23.101
Brand Name
Kidney Assist Transport
Version/Model Number
Kidney Assist Transport
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
-
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
K211333
Product Code
KDN
Product Code Name
System, Perfusion, Kidney
Public Device Record Key
0bf747b9-fd1a-4892-b6e0-c3234dbf16d1
Public Version Date
May 12, 2022
Public Version Number
1
DI Record Publish Date
May 04, 2022
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |