763baac3-3810-4989-a04d-78a9a34c8e30UpdatePublished32018-07-062017-06-06In Commercial Distribution08809301166017PrimaryGS1Gmate® SMART Blood Glucose Monitoring SystemPG-101690184887PHILOSYS Co., Ltd1falsefalsefalsefalsefalsetruetruetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsetrueK15029900062537Glucose 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.falseActiveCGAGlucose Oxidase, GlucoseNBWSystem, Test, Blood Glucose, Over The Counterfalsefalse