AccessGUDID - DEVICE: TRUE METRIX (00096295126600)

GUDID

Device Identifier (DI) Information

Brand Name: TRUE METRIX
Version or Model: TRUE METRIX Self Monitoring Blood Glucose Meter
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RE4002-01
Company Name: TRIVIDIA HEALTH, INC.

Primary DI Number: 00096295126600
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151810868 *Terms of Use

Device Description: LEADER TRUE METRIX Self Monitoring Blood Glucose Meter

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):	Yes
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Glucose 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 materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

GMDN Preferred Term Name

GMDN Definition

Glucose 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 materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

FDA Product Code

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Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter
LFR	Glucose Dehydrogenase, Glucose

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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 40 and 86 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1d222827-cf43-4a26-b82b-8cd3a5c12034
Public Version Date: November 12, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016