Catalog Number

860397

Brand Name

HeartStart MRx monitor/defib

Version/Model Number

860397

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

K031187

Product Code

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Public Device Record Key

a99a0fb3-3ccc-4670-8b54-a9c1a8105e78

Public Version Date

November 24, 2021

Public Version Number

4

DI Record Publish Date

August 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-