Easy Talk Control Solution - HIGH - Blood glucose control solution for use with Easy - HOME AIDE DIAGNOSTICS, INC.

Duns Number:783518983

Device Description: Blood glucose control solution for use with Easy Talk blood glucose testing system

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More Product Details

Catalog Number

1522

Brand Name

Easy Talk Control Solution - HIGH

Version/Model Number

GOD31

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

Yes

FDA Premarket Submission

-

Product Code Details

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

bf7ba7d2-158e-4143-abe5-57bf8440a84c

Public Version Date

October 03, 2019

Public Version Number

4

DI Record Publish Date

May 01, 2016

Additional Identifiers

Package DI Number

10891237001529

Quantity per Package

100

Contains DI Package

00891237001522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Case

"HOME AIDE DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 44
U Unclassified 11