4c201141-3c80-4ae6-9bb1-79e3a22958b9UpdatePublished22020-09-092020-08-19In Commercial Distribution20612479197354PackageGS1106124792504411In Commercial DistributionBox10612479250441PrimaryGS140612479197365PackageGS12061247919735424In Commercial DistributionCaseMckesson06-R5051-2023904428MCKESSON MEDICAL-SURGICAL INC.1CONTROL, BLD GLUCOSE LEVEL 2 T falsefalsefalsefalsefalsefalsetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationfalsetrue60740Home-use blood glucose spot-check systemAn electrically-powered, portable device assembly intended to spot-check (user-initiated) measure and display blood glucose concentration in a patient with diabetes mellitus; it is not intended for continuous measurements (i.e., not a monitor). It includes a quantitative glucose meter that uses a blood specimen for the personal calibration of a noninvasive qualitative measurement device (e.g., near-infrared spectroscopy) which performs the measurements, typically on a finger, without blood draw; it also includes test strips, lancets, control solutions, and associated materials. It is designed to be used by a layperson in the home, and some types may in addition be used at the point-of-care.falseActiveNBWSystem, Test, Blood Glucose, Over The CounterLFRGlucose Dehydrogenase, Glucosefalsefalse