Catalog Number

1005-00010-US

Brand Name

Cardioskin Textile S42

Version/Model Number

1005-00010-US

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173248

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

95b33297-f590-40d5-8d97-32449375134b

Public Version Date

February 22, 2019

Public Version Number

1

DI Record Publish Date

January 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-