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 or two kidneys. The kidneys are attached to the arterial ports either in single fashion, or can be placed enbloc.
Catalog Number
0012691.000
Brand Name
DCM-100 DUAL KIDNEY CASSETTE
Version/Model Number
DCM Kidney 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
K971571,K971571
Product Code
KDN
Product Code Name
System, Perfusion, Kidney
Public Device Record Key
ad7f8d59-ed95-495c-8c4e-b0ba5b415996
Public Version Date
March 20, 2019
Public Version Number
4
DI Record Publish Date
February 12, 2017
Package DI Number
0008190000
Quantity per Package
4
Contains DI Package
B154R00126910000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |