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

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

JIN

Product Code Name

Nitroprusside, Ketones (Urinary, Non-Quant.)

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

Package DI Number

10370393216102

Quantity per Package

400

Contains DI Package

00370393216105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-