Care Touch - Blood Ketone Test strips - FUTURE DIAGNOSTICS LLC

Duns Number:080113296

Device Description: Blood Ketone Test strips

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More Product Details

Catalog Number

-

Brand Name

Care Touch

Version/Model Number

CTk-10

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161738,K161738,K161738

Product Code Details

Product Code

JIN

Product Code Name

Nitroprusside, Ketones (Urinary, Non-Quant.)

Device Record Status

Public Device Record Key

25e1fd1d-af70-4c47-b4a4-45630f5efcec

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

February 16, 2018

Additional Identifiers

Package DI Number

10370393216102

Quantity per Package

400

Contains DI Package

00370393216105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FUTURE DIAGNOSTICS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 5