Home GUDID 00021292014797 TRUE METRIX
Primary DI 00021292014797
Brand TRUE METRIX
Company TRIVIDIA HEALTH, INC.
Model TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM
Catalog number RE4081-03
Device description TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM Starter Kit - FOR HUMANA
Published 2021-08-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true Product Codes# Code, Name table Code Name LFR Glucose Dehydrogenase, Glucose NBW System, Test, Blood Glucose, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LFR Glucose Dehydrogenase, Glucose Clinical Chemistry 2 NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00021292007690 Direct Marking GS1 0 10021292014794 Package GS1 12 In Commercial Distribution 00021292014797 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00021292007690 00021292007690 021292007690 0021292007690 10021292014794 10021292014794 00021292014797 00021292014797 021292014797 0021292014797
GMDN Terms# Term, Definition table Term 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature 40 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 151810868 Device count 1 Kit true Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00050428324073 TRUEplus TRUEplus 5-bevel Pen Needle 32G 4mm S6007A32-100 2026-03-17 10050428324070 TRUEplus TRUEplus 5-bevel Pen Needle 32G 4mm S6007A32-100 2026-03-17 00041260007354 TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose Mete REA4203-01 2026-02-09 10041260007351 TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose Mete REA4203-01 2026-02-09 00021292015381 TRUE METRIX PRO TRUE METRIX PRO Professional Blood Glucose Monitor 2025-12-02 10840330705698 TRUE METRIX PRO TRUE METRIX PRO Professional Blood Glucose Monitor 2025-12-02 00075450843576 TRUE METRIX GO TRUE METRIX GO Self-Monitoring Blood Glucose Meter RF4048-01 2025-11-26 10075450843573 TRUE METRIX GO TRUE METRIX GO Self-Monitoring Blood Glucose Meter RF4048-01 2025-11-26 10840330706541 TRUE METRIX TRUE METRIX Control Solution - Level 1 and Level 3 R5212-13 2025-11-25 30840330706545 TRUE METRIX TRUE METRIX Control Solution - Level 1 and Level 3 R5212-13 2025-11-25 00021292009120 TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STR 2016-09-24 00021292007256 TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER RE4023-01 2016-09-20 00021292007843 TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STR R3NPD03, RF3TVH70 2016-09-20 00021292007874 TRUE METRIX PRO TRUE METRIX PRO BLOOD GLUCOSE TEST STRIPS - 10 Tes 2016-09-20 00021292012236 TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Test Str 2018-02-01 00021292012779 TRUEplus TRUEplus 3-Bevel Pen Needle 29G/12mm - 100ct box S5H01F29-100TC 2019-02-20 00021292012786 TRUEplus TRUEplus 3-Bevel Pen Needle 31G/5mm - 100ct box S5H01B31-100TC 2019-02-20 00021292012793 TRUEplus TRUEplus 3-Bevel Pen Needle 31G/6mm - 100ct box S5H01C31-100TC 2019-02-20 00021292012809 TRUEplus TRUEplus 3-Bevel Pen Needle 31G/8mm - 100ct box S5H01D31-100TC 2019-02-20 00021292012816 TRUEplus TRUEplus 3-Bevel Pen Needle 32G/4mm - 100ct box S5H01A32-100TC 2019-02-20
Other Devices Sharing Product Codes# 
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