Duns Number:790888833
Device Description: Collection of medical components used to withdraw blood samples for use in determinations Collection of medical components used to withdraw blood samples for use in determinations of total blood and plasma volumes.
Catalog Number
-
Brand Name
BVA-100 Convenience Kits
Version/Model Number
BVA-100 CONVKIT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
KST
Product Code Name
System, Blood Collection, Vacuum-Assisted, Manual
Public Device Record Key
15d68396-afcd-4752-8652-49abd3fe14ce
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |