Duns Number:838024255
Device Description: VanishPoint® Blood Collection Tube Holder Small Tube Adapter
Catalog Number
22711
Brand Name
VanishPoint®
Version/Model Number
22711
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K971763,K971763
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
9aa867b8-f821-443f-b33e-c1441b53740b
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 22, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 77 |