Duns Number:002054419
Device Description: Five Chamber Transfer/Freezing Bag Set intended to be used for cord blood processing and f Five Chamber Transfer/Freezing Bag Set intended to be used for cord blood processing and freezing
Catalog Number
791-12
Brand Name
Briostor™ Transfer/Freezing Bag Set
Version/Model Number
791-12
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"
Yes
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
BK150314,BK150314
Product Code
OAO
Product Code Name
Cord blood processing system and storage container
Public Device Record Key
d9cd9130-4928-4004-99d0-123e6881562f
Public Version Date
September 23, 2019
Public Version Number
4
DI Record Publish Date
July 20, 2016
Package DI Number
30636207314681
Quantity per Package
24
Contains DI Package
00636207314680
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |