FDA.reportPublic FDA data

Easy Talk Control Solution - HIGH

Primary DI
00891237001522
Brand
Easy Talk Control Solution - HIGH
Company
HOME AIDE DIAGNOSTICS, INC.
Model
GOD31
Catalog number
1522
Device description
Blood glucose control solution for use with Easy Talk blood glucose testing system
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
10891237001529PackageGS1100In Commercial Distribution
20891237001526PackageGS120In Commercial Distribution
00891237001522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089123700152910891237001529
2089123700152620891237001526
00891237001522008912370015228912370015220891237001522

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at temperatures between 46-86oF (8-30oC).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
783518983
Device count
1
HCT/P
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00850632007553Pure Air Mini NebulizerMCN-S600A2020-03-24
00891237001607Easy Air Compressor NebulizerMCN-S600MC16072016-05-01
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00850027494388Ultra Comfort Body Massager43882024-10-08

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