00ecc759-12e7-4eda-834b-263981c7afa4NewPublished12025-12-092025-12-01In Commercial Distribution40612479280494PackageGS11061247928048660In Commercial DistributionCase10612479280486PrimaryGS1McKessonALL03AM0201GM023904428MCKESSON MEDICAL-SURGICAL INC.1Blood Glucose Meter falsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsetrueLabeling does not contain MRI Safety InformationfalsetrueK08362800060740Home-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.falseActiveLFRGlucose Dehydrogenase, GlucoseNBWSystem, Test, Blood Glucose, Over The Counterfalsefalse