AccessGUDID - DEVICE: VF1000LED Vein locator (07898915128789)

GUDID

Device Identifier (DI) Information

Brand Name: VF1000LED Vein locator
Version or Model: VF1000LEDBX1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA

Primary DI Number: 07898915128789
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 902645407 *Terms of Use

Device Description: A device designed to locate veins through cutaneous transillumination.

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):	No
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?
36761	Visible-light skin transilluminator	An electrically-powered device intended to use visible light (e.g., red LED light) to illuminate the skin and subcutaneous soft tissues, rendering them translucent for examination. It is typically used to help locate peripheral veins beneath the skin to assist a healthcare professional during venipuncture or sclerotherapy, or for examining subcutaneous and scrotal tissue/contents for lesions or anatomical abnormalities. It is typically a portable hand-held device which may also be known as a vein finder/viewer, diaphanoscope, phaneroscope, or light scanner.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJN	Transilluminator, Battery-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: 604f7fc2-ad41-4e02-84ae-ba6f2073933a
Public Version Date: March 03, 2025
Public Version Number: 2
DI Record Publish Date: June 07, 2024