FDA.reportPublic FDA data

IDEAL LIFE Control Solution Level II

Primary DI
00804084000150
Brand
IDEAL LIFE Control Solution Level II
Company
Ideal Life Inc
Model
GCS0104
Device description
For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions contains a known amount of glucose that reacts with the test strips.
Published
2019-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
10804084000157PackageGS1200In Commercial Distribution
20804084000154PackageGS1100In Commercial Distribution
30804084000151PackageGS11In Commercial Distribution
40804084000158PackageGS1100In Commercial Distribution
00804084000150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080408400015710804084000157
2080408400015420804084000154
3080408400015130804084000151
4080408400015840804084000158
00804084000150008040840001508040840001500804084000150

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
Circumference56Millimeter
Height56Millimeter
Weight5Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 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
00804084000143IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips)AGS-1112 2019-07-22
10804084000102IDEAL LIFE SPO2 Manager™POM 00012016-12-02

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Primary DI, Brand, Company table
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