FDA.reportPublic FDA data

Easy Step Blood Glucose Test Strips 50ct

Primary DI
00891237001195
Brand
Easy Step Blood Glucose Test Strips 50ct
Company
HOME AIDE DIAGNOSTICS, INC.
Model
T5D2-00
Catalog number
1195
Device description
50ct box of Easy Step blood glucose test strips for use with Easy Step 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
K090629000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090629000EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMSTyson Bioresearch, Inc.2009-06-04NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30891237001196PackageGS1280In Commercial Distribution
50891237001190PackageGS12In Commercial Distribution
00891237001195PrimaryGS10
20891237001199Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3089123700119630891237001196
5089123700119050891237001190
00891237001195008912370011958912370011950891237001195
2089123700119920891237001199

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
Special Storage Condition, Specify00Store at room temperature between 46-86 oF (8-30 oC)

Contacts#

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

Regulatory Flags#

DUNS number
783518983
Device count
50
Lot or batch
true
Expiration date on label
true

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