08761e70-35e5-4b7f-ad08-87587324ad10UpdatePublished32018-11-122016-09-20In Commercial Distribution10021292007017PackageGS10002129200701012In Commercial DistributionCase00021292007010PrimaryGS100021292007720Direct MarkingGS1TRUE METRIX AIRTRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METERREA4H01-01151810868TRIVIDIA HEALTH, INC.1TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METER falsefalsefalsetruefalsefalsetruetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue+1(800)803-6025customercare@trividiahealth.com62537Glucose 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 CounterStorage Environment Temperaturefalsefalse