Catalog Number

-

Brand Name

ECG App

Version/Model Number

Feature Version 1.x

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

DEN180044

Product Code

QDA

Product Code Name

Electrocardiograph Software For Over-The-Counter Use

Public Device Record Key

44bd3e74-b8f9-4d96-9e1f-0019810de75b

Public Version Date

February 14, 2019

Public Version Number

1

DI Record Publish Date

January 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-