Home GUDID 10015482600508 Assure® Titanium Blood Glucose Test Strips
Primary DI 10015482600508
Brand Assure® Titanium Blood Glucose Test Strips
Company ARKRAY USA, INC.
Model 600050
Device description The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.
Published 2025-09-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PZI Prescription Use Blood Glucose Meter For Near-Patient Testing Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10015482600508 Package GS1 12 In Commercial Distribution 20015482600505 Package GS1 18 In Commercial Distribution 00015482600501 Primary GS1 0 50015482600506 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10015482600508 10015482600508 20015482600505 20015482600505 00015482600501 00015482600501 015482600501 0015482600501 50015482600506 50015482600506
GMDN Terms# Term, Definition table Term Definition Glucose monitoring system IVD, point-of-care A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. 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 Handling Environment Temperature 46 Degrees Fahrenheit 86 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Avoid storing test strips in direct sunlight. Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 36 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 008171162 Device count 50 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 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 30015482531776 Assure® Prism Multi Blood Glucose Meter 531177 2022-06-17
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