Duns Number:393146183
Device Description: Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of kidney, liv Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of kidney, liver and pancreas.
Catalog Number
-
Brand Name
BEL-GEN Cold Storage Solution
Version/Model Number
BEL-GEN/2000/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
K221387,K221387
Product Code
KDL
Product Code Name
Set, Perfusion, Kidney, Disposable
Public Device Record Key
28140e2b-29ab-4d2a-bd99-f20b0c495b09
Public Version Date
July 29, 2022
Public Version Number
1
DI Record Publish Date
July 21, 2022
Package DI Number
23700911900529
Quantity per Package
6
Contains DI Package
13700911900522
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 |