Duns Number:140727624
Device Description: V•Stick™ Vascular Access Set 4F
Catalog Number
391504000E
Brand Name
V•Stick™ Vascular Access Set
Version/Model Number
391504000E
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
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
39572a85-9f47-4c5b-87f6-27b3816d9992
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
20886333004182
Quantity per Package
10
Contains DI Package
00886333004188
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 1205 |