b6a1ac3a-367b-4f39-9e2e-d9c2cbdf97a8UpdatePublished32021-11-012016-09-20In Commercial Distribution20212920031352PackageGS10002129200313540In Commercial DistributionCase00021292003135PrimaryGS110212920031355PackageGS10002129200313512In Commercial DistributionCaseTRUEbalanceTRUEbalance BLOOD GLUCOSE MONITORING SYSTEMH4H01-81151810868TRIVIDIA HEALTH, INC.1TRUEbalance BLOOD GLUCOSE MONITORING SYSTEM falsefalsefalsetruefalsefalsetruetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue+1(800)803-6025customercare@trividiahealth.comK09049500062537Glucose monitoring system IVD, home-useA 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.falseActiveNBWSystem, Test, Blood Glucose, Over The CounterCGAGlucose Oxidase, GlucoseStorage Environment Temperaturefalsefalse