Easy Plus II Blood Glucose Monitoring System

Primary DI
00891237001652
Brand
Easy Plus II Blood Glucose Monitoring System
Company
HOME AIDE DIAGNOSTICS, INC.
Model
6276
Catalog number
1652
Device description
Blood Glucose Testing Monitor to be used with Easy Plus II or Easy Talk test stripsTest: GlucoseSample: Whole BloodPrinciple of the test method: Amperometric, glucose oxidaseTest sites: Fingertip, forearmMeasurement time: 6 secondsCode required: No code deviceMeasurement Range: 20~600 mg/dL (1.1~33.3mmol/L ).Batteries: 2 x AAA 1.5 V Alkaline 24A LR03
Published
2016-05-01
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
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10891237001659PackageGS15In Commercial Distribution
20891237001656PackageGS110In Commercial Distribution
00891237001652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089123700165910891237001659
2089123700165620891237001656
00891237001652008912370016528912370016520891237001652

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18009150116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
1
Serial number
true

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