Home GUDID 00804084000143
IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips)
Primary DI 00804084000143
Brand IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips)
Company Ideal Life Inc
Model AGS-1112
Published 2019-07-22
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 10804084000140 Package GS1 50 In Commercial Distribution 20804084000147 Package GS1 160 In Commercial Distribution 40804084000141 Package GS1 160 In Commercial Distribution 00804084000143 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 10804084000140 10804084000140 20804084000147 20804084000147 40804084000141 40804084000141 00804084000143 00804084000143 804084000143 0804084000143
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.
Device Sizes# Type, Value, Unit table Type Value Unit Height 6 Centimeter Length 7 Centimeter Weight 50 Gram Width 4 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 0 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 4 Degrees Celsius 30 Degrees Celsius Storage Environment Humidity 0 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 4 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 205155174 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 00804084000105 IDEAL LIFE SPO2 Manager™ POM 0001 2016-12-02 10804084000065 IDEAL LIFE SPO2 Manager™ POM 0001 2016-11-18 10804084000010 IDEAL LIFE BP-Manager™ BPM 0001 2016-09-23 00804084000112 IDEAL LIFE BP-Manager™ BPM 0001 2017-04-21 30804084000144 IDEAL LIFE Blood Glucose Test Strips 1 vial of 25 Test Strips AGS-1112 2019-08-02 00804084000150 IDEAL LIFE Control Solution Level II GCS0104 2019-07-17 10804084000102 IDEAL LIFE SPO2 Manager™ POM 0001 2016-12-02
Other Devices Sharing Product Codes#