FDA.reportPublic FDA data

Easy Trak Blood Glucose Test Strips 25ct

Primary DI
00891237001423
Brand
Easy Trak Blood Glucose Test Strips 25ct
Company
HOME AIDE DIAGNOSTICS, INC.
Model
200020049
Catalog number
1423
Device description
25ct bottle Easy Trak blood glucose test strips for use with Easy Trak blood glucose monitoring system
Published
2016-05-03
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
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090389000AP-1000 BLOOD GLUCOSE MONITORING SYSTEMBestgen Biotech Corp.2009-07-14NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10891237001420PackageGS12In Commercial Distribution
20891237001427PackageGS1120In Commercial Distribution
40891237001421PackageGS180In Commercial Distribution
00891237001423PrimaryGS10
50891237001428Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089123700142010891237001420
2089123700142720891237001427
4089123700142140891237001421
00891237001423008912370014238912370014230891237001423
5089123700142850891237001428

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-915-0116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
25
Lot or batch
true
Expiration date on label
true

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