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Electrocardiograph, Ambulatory (Without Analysis)

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Name
Company Name
Description
0
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DR200
Northeast Monitoring, Inc.
DR200 holter recorder w/ 7L patient cable
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DR200
Northeast Monitoring, Inc.
DR200 holter recorder w/ 5L patient cable
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DR200
Northeast Monitoring, Inc.
DR200 holter recorder w/ 2L patient cable
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LX Event
Northeast Monitoring, Inc.
LX Event Tool (TelePro)
0
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DR400
Northeast Monitoring, Inc.
DR400 holter recorder with NEMEL002/003 patches
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Gateway
Northeast Monitoring, Inc.
Gateway NEMK156
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DR300
Northeast Monitoring, Inc.
0
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DR300
Northeast Monitoring, Inc.
DR300 holter recorder w/ 5L patient cable
0
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DR181
Northeast Monitoring, Inc.
DR181 holter recorder w/ 10L patient cable
0
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DR181
Northeast Monitoring, Inc.
DR181 holter recorder w/ 7L patient cable
0
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DR181
Northeast Monitoring, Inc.
DR181 holter recorder w/ 5L patient cable
0
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DR200
Northeast Monitoring, Inc.
DR200 holter recorder w/ 3L patient cable
0
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Biotricity
BIOTRICITY INC
0
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Mediblu
MEDIBLU MEDICAL LLC
0
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MonitorMe
Lifesignals, Inc.
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
0
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MAWI
Lifesignals, Inc.
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
0
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LifeSignals
Lifesignals, Inc.
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
0
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LifeSignals
Lifesignals, Inc.
Wearable Biosensor - ECG Remote Monitoring Biosensor
0
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LifeSignals
Lifesignals, Inc.
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
0
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HOLTER CONNECT
Lifesignals, Inc.
HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor.
0
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HOLTER CONNECT
Lifesignals, Inc.
HOLTER CONNECT business logic is a software running on cloud platform that provides interface for technician to generate Holter report on ECG data of patient, provides interface for physician to access and e-sign the Holter Report generated by the ECG technician.
0
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CorVitals
Lifesignals, Inc.
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
0
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CORVITALS
Lifesignals, Inc.
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
0
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Advance Biometrix
Lifesignals, Inc.
Wearable Biosensor - ECG Remote Monitoring Biosensor
0
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Advance Biometrix
Lifesignals, Inc.
Wearable Biosensor - ECG Remote Monitoring Biosensor
0
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Actiwave
CAMNTECH LIMITED
Ambulatory ECG recorder with accelerometer - single channel
0
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Actiwave
CAMNTECH LIMITED
Ambulatory ECG/EEG recorder - four channel
0
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Actiwave
CAMNTECH LIMITED
Ambulatory Electromyogram (EMG) - two channel
0
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Actiwave
CAMNTECH LIMITED
Ambulatory ECG/EEG recorder - two channel
0
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Actiwave
CAMNTECH LIMITED
Ambulatory ECG/EEG recorder - single channel
0
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PER900 Preventice
BRAEMAR MANUFACTURING, LLC
ENHANCED ALGORITHM ECG EVENT RECORDER
0
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PER900 Braemar
BRAEMAR MANUFACTURING, LLC
ENHANCED ALGORITHM ECG EVENT RECORDER
0
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ER920 Rozinn, AFIB
BRAEMAR MANUFACTURING, LLC
ENHANCED ALGORITHM ECG EVENT RECORDER
0
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ER920 Rozinn
BRAEMAR MANUFACTURING, LLC
ENHANCED ALGORITHM ECG EVENT RECORDER
0
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ER920 Braemar, AFIB
BRAEMAR MANUFACTURING, LLC
ENHANCED ALGORITHM ECG EVENT RECORDER
0
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ER920 Braemar
BRAEMAR MANUFACTURING, LLC
ENHANCED ALGORITHM ECG EVENT RECORDERhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652#
0
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DL900
BRAEMAR MANUFACTURING, LLC
0
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DL900 Standard
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL900 Remote Analysis
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL900 Norav 7 day CE
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL900 Norav Encrypted
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL900 Forest Medical
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL900 Base
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL900 Burdick 4250
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL900 Biomedical SyS
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL900 Braemar 7day
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL900 Braemar SD
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL900 Amedtec SD
BRAEMAR MANUFACTURING, LLC
Holter Recorder
0
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DL950 Braemar Standard
BRAEMAR MANUFACTURING, LLC
0
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DL950 Braemar Base
BRAEMAR MANUFACTURING, LLC
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