Home GUDID 00850017460287 BIOCOACH Blood Glucose Test Strips 50 Pack (Foil)
Primary DI 00850017460287
Brand BIOCOACH Blood Glucose Test Strips 50 Pack (Foil)
Company AMVENTUREX, INC.
Model S5640936
Catalog number S5640936
Device description 50s
Published 2023-05-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 00850017460287 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 00850017460287 00850017460287 850017460287 0850017460287
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.
Regulatory Flags# DUNS number 117225590 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 00850017460089 BIOCOACH Blood Ketone Test Strips 50 Pack (Foil) S5640934 S5640934 2023-05-31 00850017460027 BIOCOACH Blood Glucose Test Strips 50s S5640989 S5640989 2021-12-28 00850017460034 BIOCOACH Blood Glucose and Ketone Monitoring System S84102 S84102 2021-12-28 00850017460058 BIOCOACH Glucose Control Solution L1/L2 S5800382 S5800382 2021-12-28 00850017460065 BIOCOACH Blood Glucose Test Strips 25s S5640988 S5640988 2021-12-28 00860060002310 KETOCOACH BLOOD KETONE METER s11006 2019-12-30 00860060002327 KETOCOACH 50 BLOOD KETONE TEST STRIPS S5640791 2019-12-30 00860060002334 KETOCOACH CONTROL SOLUTION Level 2 S5800335 2019-12-30 00860060002341 KETOCOACH METER ONLY S11007 2019-12-30
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