Duns Number:071926350
Device Description: The VASOBand is a compression device to assist hemostasis of the radial artery after a tra The VASOBand is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Catalog Number
VB-2900-AL
Brand Name
VASOBand
Version/Model Number
VB-2900-AL
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
K190318,K190318
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
aa99e03f-fbd6-4307-82c1-25c637a9ca53
Public Version Date
January 13, 2021
Public Version Number
1
DI Record Publish Date
January 05, 2021
Package DI Number
00860004749745
Quantity per Package
5
Contains DI Package
00866691000343
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |