Duns Number:559895730
Device Description: Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transport Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.Package size: 8x 1000 ml
Catalog Number
19017
Brand Name
Perfadex with THAM
Version/Model Number
19017
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2017
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDN
Product Code Name
System, Perfusion, Kidney
Public Device Record Key
39dbe32c-b8a1-45e6-a361-5b9f7fdf431a
Public Version Date
December 05, 2019
Public Version Number
4
DI Record Publish Date
June 13, 2016
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. | 9 |
| 3 | A medical device with high risk that requires premarket approval | 7 |