ce5009d5-4379-46ee-b693-9935781f28e9UpdatePublished42020-09-092016-12-09In Commercial Distribution10612479212784PrimaryGS100612479218543Unit of UseGS120612479197156PackageGS1106124792127842In Commercial DistributionBox40612479197167PackageGS12061247919715620In Commercial DistributionCaseMcKesson5059023904428MCKESSON MEDICAL-SURGICAL INC.25GLUCOSE TEST STRIP WITH PURPLE COLOR falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK09205200060740Home-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.falseActiveCGAGlucose Oxidase, Glucosefalsefalse