Duns Number:559895730
Device Description: PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.Package size: 10 x 1000ml
Catalog Number
19850
Brand Name
PERFADEX Plus (Click US)
Version/Model Number
19850
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
K170826
Product Code
KDN
Product Code Name
System, Perfusion, Kidney
Public Device Record Key
b26955f0-fa28-4104-a467-27702b702269
Public Version Date
December 12, 2019
Public Version Number
1
DI Record Publish Date
December 04, 2019
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 |