AccessGUDID - DEVICE: eBuricacid (04712558761116)

GUDID

Device Identifier (DI) Information

Brand Name: eBuricacid
Version or Model: eB-U01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: VISGENEER, INC.

Primary DI Number: 04712558761116
Issuing Agency: GS1
Commercial Distribution End Date: January 17, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 656031619 *Terms of Use

Device Description: blood uric acid monitoring system contains meter 1pcs, test strip 25pcs, lancing device 1pcs and lancet 25pcs

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:	Yes
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?
62221	Uric acid monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips, and/or other associated disposable materials intended to be used for the quantitative measurement of uric acid in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It is used to monitor the effectiveness of uric acid control in various disorders (e.g., renal failure, gout, leukaemia), and in patients receiving cytotoxic chemotherapy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JHC	Acid, Uric, Uricase (Oxygen Rate)

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: ad0a9f5b-59cc-41d7-b2ad-48a3e4959e25
Public Version Date: February 13, 2025
Public Version Number: 2
DI Record Publish Date: July 05, 2023