Duns Number:393146183
Device Description: Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hyp Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Catalog Number
-
Brand Name
PERF-GEN Pulsatile Perfusion Solution
Version/Model Number
PERF-GEN/1000/US
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
K221386,K221386
Product Code
KDL
Product Code Name
Set, Perfusion, Kidney, Disposable
Public Device Record Key
c079104f-347c-4323-a3b1-170012f7b034
Public Version Date
August 04, 2022
Public Version Number
1
DI Record Publish Date
July 27, 2022
Package DI Number
23700911900499
Quantity per Package
10
Contains DI Package
13700911900492
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |