Home GUDID 30015482541997 GLUCOCARD® Shine Blood Glucose Monitoring System
Primary DI 30015482541997
Brand GLUCOCARD® Shine Blood Glucose Monitoring System
Company ARKRAY USA, INC.
Model 541199
Device description Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU
Published 2016-09-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name CGA GLUCOSE OXIDASE, GLUCOSE 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 NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30015482541997 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30015482541997 30015482541997
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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Test Strips 34-86 F
Meter 32-122 F Special Storage Condition, Specify 0 0 Test Strips 34-86 FMeter 32-122 F Storage Environment Temperature 32 Degrees Fahrenheit 122 Degrees Fahrenheit Storage Environment Temperature 34 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 008171162 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 04987486009801 AUTION Check Plus Controls 102478 2020-02-26 04987486001959 S.G. Calibrator H 100672 2017-04-12 04987486053002 S.G. Calibrator H 111581 N/A 2025-12-19 00015482104658 AUTION MAX™ AX-4060 Analyzer 100526 2025-11-07 00015482510060 Assure® Control - Control Solution Level 2 & Level 3 510006 2025-09-26 00015482600501 Assure® Titanium Blood Glucose Test Strips 600050 2025-09-15 00015482601003 Assure® Titanium Blood Glucose Test Strips 600100 2025-09-15 00015482600013 Assure® Titanium Blood Glucose Meter 600001 2025-09-15 10015482600508 Assure® Titanium Blood Glucose Test Strips 600050 2025-09-15 10015482601000 Assure® Titanium Blood Glucose Test Strips 600100 2025-09-15 00015482510046 Assure® Control - Control Solution Level 1 510004 2019-04-01 00015482510053 Assure® Control - Control Solution Level 2 510005 2019-04-01 00015482510077 Assure® Control - Control Solution Level 3 510007 2019-04-01 00015482102913 ASSURE® ID Insulin 1cc Safety Syringe 210291 2016-09-23 00015482102951 ASSURE® ID Insulin 0.5cc Safety Syringe 210295 2016-09-23 00015482511104 GLUCOCARD® W Blood Glucose Monitoring System 511100 2019-04-01 00015482512057 GLUCOCARD® W Blood Glucose Test Strips 512050 2019-04-01 10015482102910 ASSURE® ID Insulin 1cc Safety Syringe 210291 2016-09-23 10015482102958 ASSURE® ID Insulin 0.5cc Safety Syringe 210295 2016-09-23 30015482501779 Assure® Platinum Blood Glucose Meter 501177 2022-06-17
Other Devices Sharing Product Codes# 
xxx.xxx