TRUE METRIX

Basic Information

• Brand Name: TRUE METRIX
• Primary DI: 00021292007843
• Version / Model: TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 10 Test Strips
• Catalog Number: R3NPD03, RF3TVH70
• Company Name: TRIVIDIA HEALTH, INC.
• Labeler DUNS: 151810868
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 6ca760df-3ed5-43d1-93ae-4d8d405491e9

Device Description

TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 10 Test Strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	862.1345	2
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00021292007843	GS1
Unit of Use	00021292007799	GS1
Package	10021292007857	GS1	Case	24	In Commercial Distribution
Package	00021292007850	GS1	Box	1	In Commercial Distribution
Package	00021292009472	GS1	Box	1	In Commercial Distribution
Package	10021292009479	GS1	Case	24	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 40 – 86 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity