AccessGUDID - DEVICE: Venoscope (B853VT030)

GUDID

Device Identifier (DI) Information

Brand Name: Venoscope
Version or Model: VT03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VT03
Company Name: VENOSCOPE, LLC

Primary DI Number: B853VT030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 612726596 *Terms of Use

Device Description: Handheld battery operated transilluminator used to locate veins for IV therapy or blood draws in adults and pediatric patients. www.venoscope.com

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32696	Skin transilluminator, battery-powered	A hand-held, battery-powered device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HJN	Transilluminator, Battery-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941035	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 6.5 Inch
Width: 2.5 Inch

Device Record Status

Public Device Record Key: d7c8a64a-a656-428e-b97b-85efc67decf4
Public Version Date: March 23, 2020
Public Version Number: 1
DI Record Publish Date: March 13, 2020