AccessGUDID - DEVICE: Meerkat Vein Finder model (04711099370009)

GUDID

Device Identifier (DI) Information

Brand Name: Meerkat Vein Finder model
Version or Model: CM3100FF6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OPCOM INC.

Primary DI Number: 04711099370009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657204525 *Terms of Use

Device Description: Locate veins and assist with medical procedures Venipuncture and blood drawing are easier Suitable for children and elderly patients Solving the problem of difficulty in venous access Quickly respond to emergency situations and save lives

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:	Yes
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
KZA	Device, Vein Location, Liquid Crystal

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: 3c8794d1-99e9-4fe8-a0a8-0ce3e33b6e17
Public Version Date: December 30, 2024
Public Version Number: 1
DI Record Publish Date: December 20, 2024