Catalog Number

-

Brand Name

iHealth

Version/Model Number

ECG3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

DSH

Product Code Name

Recorder, Magnetic Tape, Medical

Public Device Record Key

e8fdb326-0f05-4044-8cf4-3b35341a21fc

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 10, 2019

Package DI Number

10856362005019

Quantity per Package

12

Contains DI Package

00856362005012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-