FDA.reportPublic FDA data

Easy Talk Blood Glucose Testing Strips 25ct

Primary DI
00891237001485
Brand
Easy Talk Blood Glucose Testing Strips 25ct
Company
HOME AIDE DIAGNOSTICS, INC.
Model
8818
Catalog number
1485
Device description
25 ct bottle Blood Glucose Testing Strips for use with Easy Talk or Easy Plus II monitoring systems
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10891237001482PackageGS12In Commercial Distribution
20891237001489PackageGS120In Commercial Distribution
30891237001486PackageGS120In Commercial Distribution
00891237001485PrimaryGS10
40891237001483Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089123700148210891237001482
2089123700148920891237001489
3089123700148630891237001486
00891237001485008912370014858912370014850891237001485
4089123700148340891237001483

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
25
Lot or batch
true
Expiration date on label
true

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00850027494340True Comfort Knee Compression Wrap43402024-10-08
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