AccessGUDID - DEVICE: TRUE METRIX (00021292012236)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00021292012236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 151810868 *Terms of Use

Device Description: Relion TRUE METRIX Self Monitoring Blood Glucose Test Strips - 50ct Test Strips

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):	Yes
Over the Counter (OTC):	Yes
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?
62537	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.	Active	false

FDA Product Code

[?]

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

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
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 40 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b320c4be-8f70-48fd-aa9c-ea709971de1b
Public Version Date: November 03, 2025
Public Version Number: 4
DI Record Publish Date: February 01, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10681131240168	24	00681131240161	2025-08-15	Not in Commercial Distribution	CASE
00681131240161	1	00021292012236	2025-08-15	Not in Commercial Distribution	BOX
00681131240178	2	00021292012236	2025-08-15	Not in Commercial Distribution	BOX
10681131240175	12	00681131240178	2025-08-15	Not in Commercial Distribution	CASE
00681131403221	1	00021292012236		In Commercial Distribution	BOX
10681131403228	24	00681131403221		In Commercial Distribution	CASE
00681131403238	2	00021292012236		In Commercial Distribution	BOX
10681131403235	12	00681131403238		In Commercial Distribution	CASE