Catalog Number

-

Brand Name

LifeWatch Mobile Cardiac Telemetry 3-Lead

Version/Model Number

MCT 3L-International

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K143359

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Public Device Record Key

25ee5eba-2e2b-41a8-8678-bf08ddc44aeb

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-