Catalog Number

-

Brand Name

Digital Electrocardiograph

Version/Model Number

ECG-2000

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

b0e3ed15-a93d-4585-b452-d302d53db2e3

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

December 16, 2016

Package DI Number

06937683490092

Quantity per Package

1

Contains DI Package

06937683402019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-