← Back to catalogue

Venoscope

FDA UDI

Class I (US FDA UDI)

by Venoscope, Llc

Identity

Trade Name
Venoscope FDA UDI
Generic Name
Skin transilluminator, battery-powered FDA UDI
Device Name
Handheld battery operated transilluminator used for locating veins for IV therapy and blood draws in small neonate patients. FDA UDI
Model / Reference
NT01 FDA UDI
Description
Handheld battery operated transilluminator used for locating veins for IV therapy and blood draws in small neonate patients. FDA UDI

Identifiers

Catalog Number
NT01 FDA UDI
Primary DI / UDI-DI
B853NT010 FDA UDI
510(k) Number
K941035 FDA UDI
FDA Product Code
HJN FDA UDI
GMDN Term
Skin transilluminator, battery-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.1945 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 4.5 Inch FDA UDI
Width — 2.25 Inch FDA UDI

Category: Skin transilluminator, battery-powered

Venoscope by Venoscope, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin transilluminator, battery-powered.

Cleared under the same submission

K941035 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Venoscope, Llc

Sources (1)

  • FDA UDI cd0b5a47-0d90-4737-b943-c1c2df068e4c 37 fields · synced May 30, 2026