Duns Number:612726596
Device Description: Handheld battery operated transilluminator used for locating veins for IV therapy and bloo Handheld battery operated transilluminator used for locating veins for IV therapy and blood draws in small neonate patients.
Catalog Number
NT01
Brand Name
Venoscope
Version/Model Number
NT01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K941035
Product Code
HJN
Product Code Name
Transilluminator, Battery-Powered
Public Device Record Key
cd0b5a47-0d90-4737-b943-c1c2df068e4c
Public Version Date
March 23, 2020
Public Version Number
1
DI Record Publish Date
March 13, 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 |