Home GUDID 00816703021927 MedSource Glucometer Test Solution (Normal, high)
Primary DI 00816703021927
Brand MedSource Glucometer Test Solution (Normal, high)
Company MEDSOURCE INTERNATIONAL LLC
Model MS-76016
Device description Glucometer Test Solution (Normal, high)
Published 2016-10-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use 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 00816703021927 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 00816703021927 00816703021927 816703021927 0816703021927
GMDN Terms# Term, Definition table Term Definition Home-use/point-of-care blood glucose monitoring system IVD 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 together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Regulatory Flags# DUNS number 041674552 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840155408425 MedSource Blanket MS-40521 Not Applicable 2021-07-07 00816703023617 MedSource First Aid Kit NORTH-349000 Not Applicable 2021-08-17 00816703023723 MedSource Bags NORTH-678805EM Not Applicable 2021-08-17 00816703023839 MedSource First Aid Wallet NORTH-67M08 Not Applicable 2021-08-25 00816703024034 MedSource Packed Bags SH-B1311 Not Applicable 2021-08-25 00840155404304 MedSource Body Bags MS-BOD200 Not Applicable 2021-07-28 00840155406094 MedSource Emergency Blanket MS-B100 Not Applicable 2021-07-27 00840155406162 MedSource Emergency Blanket MS-B200 Not Applicable 2021-07-27 00816703023853 MedSource Bags NORTH-67M09 Not Applicable 2021-08-25 00816703023860 MedSource Bags NORTH-67M10 Not Applicable 2021-08-25 00816703023938 MedSource Packed Bags NORTH-90LGTRAUM Not Applicable 2021-08-25 00816703023952 MedSource Packed Bags NORTH-90TRAUMAE Not Applicable 2021-08-25 00816703024058 MedSource First Aid Kit SH-B1411 Not Applicable 2021-08-25 00816703024065 MedSource Packed Bags SH-B1412 Not Applicable 2021-08-25 00816703027097 MedSource Bags MS-TLS-3-B Not Applicable 2021-08-16 00816703029473 MedSource Bags MS-33360-RCS Not Applicable 2021-08-03 00840155404540 MedSource Bags MS-B33655FP Not Applicable 2021-07-28 00840155404670 MedSource Bags MS-B3362 Not Applicable 2021-07-28 00840155407411 MedSource Bags MS-B3350R Not Applicable 2021-07-28 00840155406667 MedSource Bags MS-B3309 Not Applicable 2021-07-27
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