Duns Number:393146183
Device Description: Sterile, non-pyrogenic cold flush, storage and transport solution for Hearts.
Catalog Number
533682
Brand Name
CELSIOR Cold Storage Solution
Version/Model Number
CELSIOR 1L 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
-
Product Code
MSB
Product Code Name
System And Accessories, Isolated Heart, Transport And Preservation
Public Device Record Key
24bacde0-da18-4f31-998b-decedd1eb322
Public Version Date
February 15, 2022
Public Version Number
1
DI Record Publish Date
February 07, 2022
Package DI Number
23700911900123
Quantity per Package
4
Contains DI Package
13700911900126
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |