Duns Number:830864406
Device Description: Near infrared vein locator device with a liquid crystal display.
Catalog Number
-
Brand Name
Veinsite
Version/Model Number
VTS1000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
KZA
Product Code Name
Device, Vein Location, Liquid Crystal
Public Device Record Key
5a49e926-4762-4d10-9d87-4f12f8e6de47
Public Version Date
September 24, 2020
Public Version Number
2
DI Record Publish Date
December 04, 2018
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |