Home GUDID 00856176008056 POGO Automatic Test Cartridges
Primary DI 00856176008056
Brand POGO Automatic Test Cartridges
Company INTUITY MEDICAL, INC.
Model 00856176008056
Catalog number 00856176008056
Device description Blood glucose test cartridges with 10 tests per cartridge. Five cartridges per tube (50 tests)
Published 2020-02-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Sterile true
Single use true Product Codes# Code, Name table Code Name NBW System, Test, Blood Glucose, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50856176008051 Package GS1 12 In Commercial Distribution 00856176008056 Primary GS1 0 00856176008018 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 50856176008051 50856176008051 00856176008056 00856176008056 856176008056 0856176008056 00856176008018 00856176008018 856176008018 0856176008018
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 Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature 50 Degrees Fahrenheit 104 Degrees Fahrenheit Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 40 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 941150349 Device count 5 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 00856176008001 POGO Automatic Blood Glucose Monitoring System 00856176008001 00856176008001 2020-02-02 00856176008025 POGO Automatic Control Solution 00856176008025 00856176008025 2020-02-02 00856176008032 POGO Automatic Control Solution 00856176008032 00856176008032 2020-02-02
Other Devices Sharing Product Codes# 
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