Duns Number:265492868
Device Description: 300 mL Empty Bag for Pooling of Blood Components.
Catalog Number
VSE3010XD
Brand Name
VSE3010XD - Empty Bag 300 mL 6-Way Man
Version/Model Number
VSE
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
BK030008,BK030008
Product Code
CAK
Product Code Name
Microfilter, Blood Transfusion
Public Device Record Key
1d075fe7-fa2f-428b-956e-fed1f9e68b1c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
13567050052747
Quantity per Package
20
Contains DI Package
03567050052740
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |