FDA.reportPublic FDA data

LifeWatch Mobile Cardiac Telemetry 3-Lead

Primary DI
00850725007095
Brand
LifeWatch Mobile Cardiac Telemetry 3-Lead
Company
Lifewatch
Model
MCT 3L-ES400-ATT
Device description
3 Lead Continuous ECG Monitor & Arrhythmia Detector (ES400/Windows/ATT)
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSIDetector And Alarm, Arrhythmia
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110499000CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORCard Guard Scientific Survival , Ltd.2011-04-06DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850725007095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850725007095008507250070958507250070950850725007095

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring system transmitterA body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin temperature, or haemoglobin oxygen saturation (SpO2)] to a remote receiver (e.g., central station server); it may in addition record/analyse data during a period of time for later retrieval (Holter reporting). The transmitter typically includes an antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, and may be provided with dedicated data management/communication software. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-700-3788DL-CCCSupervisors@lifewatch.com

Regulatory Flags#

DUNS number
797936734
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850725007002LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L- Ozone-Verizon2016-09-16
00850725007019LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-ES400-Verizon2016-09-16
00850725007026LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-Brigadier-Verizon2016-09-16
00850725007033LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-Universal Gateway-Verizon2016-09-16
00850725007040LifeWatch Mobile Cardiac Telemetry 1 Lead PatchMCT 1L Patch-Universal Gateway-Verizon2016-09-16
00850725007057MicroERMicroER2016-09-16
00850725007064ExplorerExplorer2016-09-16
00850725007071King of Hearts AFKing of Hearts AF2016-09-16
00850725007088Lifestar AF ExpressLifestar AF Express2016-09-16
00850725007101LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-International2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838119769Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
20884838119776Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDSI2026-04-15
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXH2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00198953107263MACGe Medical Systems Information Technologies, Inc.DXH2026-01-27
B353UB22511UbiqVue HolterLifesignals, Inc.DXH2025-04-22
00195278421456CAMGE Medical Systems Information Technologies, Inc.DXH2025-04-07
B210AC0290K1000Alivecor, Inc.DXH2025-03-18
00840682144322MACGE Medical Systems Information Technologies, Inc.DXH2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DXH2025-03-13
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDDXH2025-02-07
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DSI2024-07-26
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DXH2024-07-26
B210AC0110KardiaBand SystemAlivecor, Inc.DXH2024-03-22
00763000613747LINQ II™MEDTRONIC, INC.DSI2023-11-19
00855778005456uCor Heart Failure and Arrhythmia Management SystemZOLL MANUFACTURING CORPORATIONDSI2023-06-22
10841522129797TruLinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2023-05-16
10841522129803TruLinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2023-05-16
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDSI2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDSI2023-04-19
00195278524089NAGE Healthcare Finland OyDSI2023-04-19
00195278276124MACGe Medical Systems Information Technologies, Inc.DXH2022-11-09
00195278288639CARESCAPE ONEGe Medical Systems Information Technologies, Inc.DSI2022-05-13
00840682146111CARESCAPE B650GE Healthcare Finland OyDSI2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyDSI2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.DSI2022-04-12