Catalog Number

81019579

Brand Name

touchECG

Version/Model Number

touchECG

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

K160746

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

189b0dd0-27e6-4a77-8472-27d0bfb6db8f

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

April 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-