LifeWatch Mobile Cardiac Telemetry 3-Lead

GUDID 00850725007002

3 Lead Continuous ECG Monitor & Arrhythmia Detector (Ozone/Windows/Verizon)

Lifewatch

Electrocardiography telemetric monitoring system transmitter
Primary Device ID00850725007002
NIH Device Record Keydd64b456-0163-4957-976d-9e48a74517ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameLifeWatch Mobile Cardiac Telemetry 3-Lead
Version Model NumberMCT 3L- Ozone-Verizon
Company DUNS797936734
Company NameLifewatch
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-700-3788
EmailDL-CCCSupervisors@lifewatch.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850725007002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXHTransmitters And Receivers, Electrocardiograph, Telephone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2016-09-16

On-Brand Devices [LifeWatch Mobile Cardiac Telemetry 3-Lead]

008507250071013 Lead Continuous ECG Monitor & Arrhythmia Detector (MCT 3L - International)
008507250070953 Lead Continuous ECG Monitor & Arrhythmia Detector (ES400/Windows/ATT)
008507250070333 Lead Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)
008507250070263 Lead Continuous ECG Monitor & Arrhythmia Detector (Brigadier/Android/Verizon)
008507250070193 Lead Continuous ECG Monitor & Arrhythmia Detector (ES400/Windows/Verizon)
008507250070023 Lead Continuous ECG Monitor & Arrhythmia Detector (Ozone/Windows/Verizon)

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