Duns Number:690543319
Device Description: TERUFLEX TRANSFER BAG
Catalog Number
-
Brand Name
TERUFLEX TRANSFER BAG
Version/Model Number
BB*T015CB70
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
KSR
Product Code Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Public Device Record Key
6fc59f4e-1fe5-4a64-9389-86e83cdf6e52
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
54987350704134
Quantity per Package
4
Contains DI Package
34987350704130
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 364 |
3 | A medical device with high risk that requires premarket approval | 29 |