AccessGUDID - DEVICE: ESU TRANSILLUMINATOR (00860003720509)

GUDID

Device Identifier (DI) Information

Brand Name: ESU TRANSILLUMINATOR
Version or Model: MK-02GX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ESU LIMITED LIABILITY PARTNERSHIP

Primary DI Number: 00860003720509
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 716244660 *Terms of Use

Device Description: The device supports the identification of veins in neonates and infants for venipuncture through the use of an LED that emits a wavelength close to the "optical window," allowing for deeper light penetration into human tissue.

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?
48040	Infrared-light vein locator	A portable, hand-held, electrically-powered device designed to help locate peripheral veins beneath the skin (subcutaneous) using infrared (IR) laser-generated light. It is intended to illuminate the position of veins on the skin surface directly above the veins to assist a healthcare professional in finding a vein of the right size and position for venipuncture. It may also be known as an IR vein finder, viewer or transilluminator, and may include a small interface screen to cycle through previously stored display settings to help optimize vein display for the patient undergoing examination/treatment.	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: 4b95d23f-716d-4e61-8527-6e06a703adf1
Public Version Date: August 03, 2023
Public Version Number: 2
DI Record Publish Date: May 01, 2020