Home GUDID 08809115908452 Element™ Meter
Primary DI 08809115908452
Brand Element™ Meter
Company OSANG HEALTHCARE Co., Ltd.
Model IGM-0021B
Device description Blood Glucose Monitoring System
Published 2017-12-11
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 CGA Glucose Oxidase, Glucose JJX Single (Specified) Analyte Controls (Assayed And Unassayed) NBW System, Test, Blood Glucose, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CGA Glucose Oxidase, Glucose Clinical Chemistry 2 JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry 1 NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08809115908452 Primary GS1 0 8522-0000-22 Secondary NDC/NHRIC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809115908452 08809115908452 8809115908452
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 0.3 Microliter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature 50 Degrees Fahrenheit 104 Degrees Fahrenheit
Regulatory Flags# DUNS number 688195374 Device count 1 Kit true Lot or batch true Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08809115905796 Oh'care Lite Smart Glucose Test Strip IGM-1003F 2020-11-05 08809115908438 Element™ Test Strips IGM-0021B 2017-12-11 08809115908957 Element™Plus Test Strips IGM-0021B 2017-07-21 08809115905369 OKRA Glucose Test Strip(25T) IGM-1003A 2021-07-27 08809115905697 OKRA Glucose Test Strip Refill kit IGM-1003A 2020-10-29 08809115905710 OKRA Glucose Test Strip IGM-1003A 2020-10-29 08809115906540 Oh'Care Lite Smart Glucose Test Strip IGM-1003F 2019-09-17 00793150629787 Oh’Care Lite Blood Glucose Test strips IGM-1003A INFS003L 2017-11-03 08809115900449 QuickFinder™ COVID-19/Flu Antigen Self Test OI-01SU-CC RCUCC02ENA1 2025-03-18 08809115900401 QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit OI-01SQ-C1 RCQC110ENA1 2025-03-12 08809115900418 QuickFinder™ COVID-19/Flu Antigen ProTest OI-01SU-CC RCUCC25ENP1 2025-03-18 08809115900425 QuickFinder™ COVID-19/Flu Antigen Self Test OI-01SU-CC RCUCC05ENA1 2025-03-18 08809115900432 QuickFinder™ COVID-19/Flu Antigen Self Test OI-01SU-CC RCUCC04ENA1 2025-03-18 08809115900456 QuickFinder™ COVID-19/Flu Antigen Self Test OI-01SU-CC RCUCC01ENA1 2025-03-17 08809115904119 CURO L5 Glucose test strip ILM-0001A INFSG001EF 2022-09-26 08809115905406 CURO L5 Meter ILM-0001A 2021-07-09 08809115905413 CURO L5 TC test strip ILM-0001A 2021-07-09 08809115905444 CURO L5 TG test strip ILM-0001A 2021-06-17 08809115905703 OKRA Glucose monitoring system starter kit IGM-1003A 2020-10-29 08809115905727 OKRA Glucose meter IGM-1003A 2020-10-29
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