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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10804084000140PackageGS150In Commercial Distribution
20804084000147PackageGS1160In Commercial Distribution
40804084000141PackageGS1160In Commercial Distribution
00804084000143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080408400014010804084000140
2080408400014720804084000147
4080408400014140804084000141
00804084000143008040840001438040840001430804084000143

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA 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
TypeValueUnit
Height6Centimeter
Length7Centimeter
Weight50Gram
Width4Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature4 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-433-2541info@ideallife.com

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 DIBrandModelCatalogPublished
00804084000105IDEAL LIFE SPO2 Manager™POM 00012016-12-02
10804084000065IDEAL LIFE SPO2 Manager™POM 00012016-11-18
10804084000010IDEAL LIFE BP-Manager™BPM 00012016-09-23
00804084000112IDEAL LIFE BP-Manager™BPM 00012017-04-21
30804084000144IDEAL LIFE Blood Glucose Test Strips 1 vial of 25 Test StripsAGS-11122019-08-02
00804084000150IDEAL LIFE Control Solution Level IIGCS01042019-07-17
10804084000102IDEAL LIFE SPO2 Manager™POM 00012016-12-02

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