DEVICE: TRUEtrack (00050428318010)
Device Identifier (DI) Information
TRUEtrack
TRUEtrack Blood Glucose Monitoring System
In Commercial Distribution
A4007-81
TRIVIDIA HEALTH, INC.
TRUEtrack Blood Glucose Monitoring System
In Commercial Distribution
A4007-81
TRIVIDIA HEALTH, INC.
CVS Health TRUEtrack Blood Glucose Monitoring System
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
Yes | |
No | |
No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NBW | System, Test, Blood Glucose, Over The Counter |
CGA | Glucose Oxidase, Glucose |
JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 40 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
731923f9-3900-4b2e-8c33-11e3a0bcd786
March 29, 2018
2
September 20, 2016
March 29, 2018
2
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10050428318017 | 12 | 00050428318010 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)803-6025
customercare@trividiahealth.com
customercare@trividiahealth.com