Home GUDID 00860396000608 ijCare
Primary DI 00860396000608
Brand ijCare
Company IJDREAM CORPORATION
Model ijCare Blood Glucose Monitoring System Kit
Published 2019-05-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 00860396000608 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 00860396000608 00860396000608 860396000608 0860396000608
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.
Regulatory Flags# DUNS number 081064046 Device count 1 Lot or batch true Expiration date on label 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 00860313000919 Oh’Care Lite Blood Glucose Monitoring System for Self-Testing IGM-1003A INFM003L 2018-06-30
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00682607551354 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551361 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551378 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815234 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815241 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815258 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815265 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551385 ON CALL® SURE BLOOD CONTROL SOLUTION Acon Laboratories, Inc. NBW 2026-07-30 00682607551392 ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607551408 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551422 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551439 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551446 ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607551453 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551460 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551477 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607815098 ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607815104 ON CALL® SURE GK BLOOD GLUCOSE & KETONE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607815111 ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607815272 ON CALL® SURE KETONE CONTROL SOLUTION Acon Laboratories, Inc. NBW 2026-07-30 00816042013652 FORA FORA CARE INC. LFR 2026-07-20 00850078377265 iHealth iHealth Labs Inc. NBW 2026-07-14 00860015091604 KetoBM KETOBM USA LLC NBW 2026-07-14 00860015091611 KetoBM KETOBM USA LLC NBW 2026-07-14 00860015091628 KetoBM KETOBM USA LLC NBW 2026-07-14 00860015091635 KetoBM KETOBM USA LLC NBW 2026-07-14 04719869706904 Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706911 TysonBio AC500 PRO Blood Glucose Test Strips (50T) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706928 Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706942 Tyson Bio AC500 PRO Control Solution (Level 1) (FDA) TYSON BIORESEARCH INC. NBW 2026-07-13