Home GUDID 00850725007071 King of Hearts AF
Primary DI 00850725007071
Brand King of Hearts AF
Company Lifewatch
Model King of Hearts AF
Device description King of Hearts Express AF Cardiac Event Recorder
Published 2016-09-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DSH Recorder, Magnetic Tape, Medical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DSH Recorder, Magnetic Tape, Medical Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850725007071 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850725007071 00850725007071 850725007071 0850725007071
GMDN Terms# Term, Definition table Term Definition Electrocardiography telemetric monitoring system transmitter A 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.
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 DI Brand Model Catalog Published 00850725007002 LifeWatch Mobile Cardiac Telemetry 3-Lead MCT 3L- Ozone-Verizon 2016-09-16 00850725007019 LifeWatch Mobile Cardiac Telemetry 3-Lead MCT 3L-ES400-Verizon 2016-09-16 00850725007026 LifeWatch Mobile Cardiac Telemetry 3-Lead MCT 3L-Brigadier-Verizon 2016-09-16 00850725007033 LifeWatch Mobile Cardiac Telemetry 3-Lead MCT 3L-Universal Gateway-Verizon 2016-09-16 00850725007040 LifeWatch Mobile Cardiac Telemetry 1 Lead Patch MCT 1L Patch-Universal Gateway-Verizon 2016-09-16 00850725007057 MicroER MicroER 2016-09-16 00850725007064 Explorer Explorer 2016-09-16 00850725007088 Lifestar AF Express Lifestar AF Express 2016-09-16 00850725007095 LifeWatch Mobile Cardiac Telemetry 3-Lead MCT 3L-ES400-ATT 2016-09-16 00850725007101 LifeWatch Mobile Cardiac Telemetry 3-Lead MCT 3L-International 2016-09-16
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