TRUEtrack

Basic Information

• Brand Name: TRUEtrack
• Primary DI: 00021292008888
• Version / Model: TRUEtrack 25 Blood Glucose Test Strips
• Company Name: TRIVIDIA HEALTH, INC.
• Labeler DUNS: 151810868
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 8
• Public Version Date: 2021-11-22
• Public Version Status: Update
• Public Device Record Key: 4c452f75-6a89-42b2-aa51-12e0d6bcee80

Device Description

TRUEtrack 25 Blood Glucose Test Strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
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	00021292008888	GS1
Unit of Use	00021292007751	GS1
Package	00311917104881	GS1	Box	1	Not in Commercial Distribution	2017-07-31
Package	10050428288877	GS1	Case	24	In Commercial Distribution
Package	00021292002930	GS1	Box	1	Not in Commercial Distribution	2021-03-16
Package	10021292002937	GS1	Case	24	Not in Commercial Distribution	2021-03-16
Package	00011822359870	GS1	Box	1	Not in Commercial Distribution	2021-11-10
Package	10011822359877	GS1	Case	24	Not in Commercial Distribution	2021-11-10
Package	00010939264442	GS1	Box	1	Not in Commercial Distribution	2017-08-29
Package	10010939264449	GS1	Case	24	Not in Commercial Distribution	2017-08-29
Package	00041220660803	GS1	Box	1	Not in Commercial Distribution	2019-10-08
Package	10041220660800	GS1	Case	24	Not in Commercial Distribution	2019-10-08
Package	00041415050785	GS1	Box	1	Not in Commercial Distribution	2020-01-01
Package	10041415050782	GS1	Case	24	Not in Commercial Distribution	2020-01-01
Package	00050428288870	GS1	Box	1	In Commercial Distribution
Package	00050428421734	GS1	BOX	1	In Commercial Distribution
Package	10050428421731	GS1	CASE	24	In Commercial Distribution
Package	10311917104888	GS1	Case	24	Not in Commercial Distribution	2017-07-31

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K032657	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 40 – 86 Degrees Fahrenheit