Catalog Number

-

Brand Name

Digital Electrocardiograph

Version/Model Number

iE101

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

K160092,K160092

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

5c93a5fa-6f05-4ce4-a12c-b795fd753236

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

October 18, 2016

Package DI Number

06937683490108

Quantity per Package

1

Contains DI Package

06937683411448

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-