Duns Number:029062325
Device Description: Plasma Pooling Set-1000mL Collection Bag w/(3) 400mL Aliquot Bags and Distal Needle Adapte Plasma Pooling Set-1000mL Collection Bag w/(3) 400mL Aliquot Bags and Distal Needle Adapter
Catalog Number
T8703H
Brand Name
N/A
Version/Model Number
T8703H
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
BK960043,BK960043
Product Code
KSR
Product Code Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Public Device Record Key
2e1f18fa-9083-49cb-a668-f9dc2eddc18f
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
00817827025792
Quantity per Package
24
Contains DI Package
00817827025297
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| U | Unclassified | 7 |