Catalog Number

-

Brand Name

Care Touch

Version/Model Number

CTk-215

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

-

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

Product Code

JIN

Product Code Name

Nitroprusside, Ketones (Urinary, Non-Quant.)

Public Device Record Key

1ee8d519-95b5-4f0a-9a7b-13c230067191

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

February 05, 2018

Package DI Number

10370393215204

Quantity per Package

40

Contains DI Package

00370393215207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-