Duns Number:488052341
Catalog Number
10041
Brand Name
CryoSC-Db Freezing Bag
Version/Model Number
FB-100.2b
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
BK090037,BK090037
Product Code
OOF
Product Code Name
Cryogenic Cord Blood Storage Container
Public Device Record Key
a6777d70-8a8a-4f5c-862c-8e10b0e85b32
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
January 13, 2017
Package DI Number
07640125650419
Quantity per Package
24
Contains DI Package
07640125650402
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |