Home GUDID 00860313000919 Oh’Care Lite Blood Glucose Monitoring System for Self-Testing
Primary DI 00860313000919
Brand Oh’Care Lite Blood Glucose Monitoring System for Self-Testing
Company IJDREAM CORPORATION
Model IGM-1003A
Catalog number INFM003L
Device description Blood Glucose Monitoring System for Self-Testing
Published 2018-06-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name LFR Glucose Dehydrogenase, Glucose NBW System, Test, Blood Glucose, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LFR Glucose Dehydrogenase, Glucose Clinical Chemistry 2 NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860313000919 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860313000919 00860313000919 860313000919 0860313000919
GMDN Terms# Term, Definition table Term Definition Glucose monitoring system IVD, home-use A 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.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 0.5 Microliter
Regulatory Flags# DUNS number 081064046 Device count 1 Kit true Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860396000615 Oh’Care Lite Blood Glucose Test strips IGM-1003A INFS003L 2018-06-30 00860313000933 Oh'Care Lite Oh'Care Lite Control Solution INFCN003L 2023-03-31 00850002937428 ijCare ijCare Blood Glucose Monitoring System Kit 2020-02-28 00860396000608 ijCare ijCare Blood Glucose Monitoring System Kit 2019-05-23
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