Duns Number:556957871
Device Description: The cassette is a self-contained circulation system consisting of an organ chamber, a veno The cassette is a self-contained circulation system consisting of an organ chamber, a venous and arterial reservoir, a bubble trap, a membrane oxygenator, a heat exchanger and pulsatile pump head. The system can provide circulation of one liter of PPS (machine perfusate) to one kidney. The kidney is attached to the arterial ports either in single fashion, or can be placed enbloc.
Catalog Number
3930005.014
Brand Name
WCM Cassette (included in WCM cassettes kit) - 1/sterile bag
Version/Model Number
WCM Cassette
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111521
Product Code
KDN
Product Code Name
System, Perfusion, Kidney
Public Device Record Key
02db59ad-011f-4d97-81f9-f2a98c422480
Public Version Date
March 21, 2019
Public Version Number
4
DI Record Publish Date
February 12, 2017
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. | 53 |