AccessGUDID - DEVICE: Uric Acid Test Strip (06935740727006)

GUDID

Device Identifier (DI) Information

Brand Name: Uric Acid Test Strip
Version or Model: PA 11,25strips/vial×2/box
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Urit Medical Electronic Co., Ltd.

Primary DI Number: 06935740727006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 653742429 *Terms of Use

Device Description: No description.

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?
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
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9868e567-f1af-40de-acd9-31ea03e70704
Public Version Date: July 22, 2024
Public Version Number: 1
DI Record Publish Date: July 12, 2024