Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AB-YXXXB
Not in Commercial Distribution

  • 00812345027259 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AB-AXXXD
Not in Commercial Distribution

  • 00812345027242 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-YXXXD
Not in Commercial Distribution

  • 00812345027235 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-AXXXC
Not in Commercial Distribution

  • 00812345027228 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-AXXXB
In Commercial Distribution

  • 00812345027211 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-AXXXA
Not in Commercial Distribution

  • 00812345027204 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AB-AXXXB
In Commercial Distribution

  • 00812345027198 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AXXXX
Not in Commercial Distribution

  • 00812345027181 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AXXXC
Not in Commercial Distribution

  • 00812345027174 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AXXXB
Not in Commercial Distribution

  • 00812345027167 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AAXXX
Not in Commercial Distribution

  • 00812345027150 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AAXXC
Not in Commercial Distribution

  • 00812345027143 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AAXXB
Not in Commercial Distribution

  • 00812345027136 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AAXXA
Not in Commercial Distribution

  • 00812345027129 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0621-08
In Commercial Distribution

  • B146C4MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0621-02
In Commercial Distribution

  • B146C4MA020 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0621-00
In Commercial Distribution

  • B146C4MA000 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0620-08
In Commercial Distribution

  • B146C3MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0620-07
In Commercial Distribution

  • B146C3MA070 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0620-05
In Commercial Distribution

  • B146C3MA050 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0620-02
In Commercial Distribution

  • B146C3MA020 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0620-00
In Commercial Distribution

  • B146C3MA00 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0619-08
In Commercial Distribution

  • B146C2MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0619-00
In Commercial Distribution

  • B146C2MA000 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0618-08
In Commercial Distribution

  • B146C1MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0618-07
In Commercial Distribution

  • B146C1MA070 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-05
In Commercial Distribution

  • B146C1MA051010 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-04
In Commercial Distribution

  • B146C1MA041010 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-03
In Commercial Distribution

  • B146C1MA031010 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-02
In Commercial Distribution

  • B146C1MA021010 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmia. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-00
In Commercial Distribution

  • B146C1MA001010 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
The Millennia software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-01
In Commercial Distribution

  • B146C1MA011010 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Server Analyzer
Lifesignals, Inc.
UA2251-SA
In Commercial Distribution

  • B353UA2251SA1 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Desktop Analyzer
Lifesignals, Inc.
UA2251-DA
In Commercial Distribution

  • B353UA2251DA1 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
Infobionic, Inc.
1400
In Commercial Distribution

  • B690MS10 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing a Windows platform.
SPAULDING MEDICAL
3.0.6.1
In Commercial Distribution

  • B441SMWINCLIENTAPP0 ()
SMWINCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution

  • B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.
SPAULDING MEDICAL
1.2.6.1
In Commercial Distribution

  • B441SMANDCLIENTAPP0 ()
SMANDCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting Software Dongle - Mini 1200/1201 2 & 3 CH ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020337 ()
A10-0122-02

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Software & Dongle - Mini 1200/1201 2 & 3 CH ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020320 ()
A10-0122-01

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting S/W & Dongle- Mini 1200 / 1201, 2 & 3 CH ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020313 ()
A10-0122-00

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS S/W & Dongle, Comb (3 CH ECG & ABP), USB w/Bluetooth
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020306 ()
A10-0118-70

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS ABP Analysis & Reporting Software & Dongle w/Bluetooth
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020290 ()
A10-0118-60

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS ABP Analysis & Reporting Software & Dongle
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020283 ()
A10-0118-50

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS S/W & Dongle, Comb (12 CH ECG & ABP),USB w/Bluetooth
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020276 ()
A10-0118-40

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting S/W Dongle Only, Comb (12 CH ECG & ABP)
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020269 ()
A10-0118-32

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting S/W & Dongle, Comb (12 CH ECG & ABP), USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020252 ()
A10-0118-30

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting S/W Dongle Only, Comb (3 CH ECG & ABP)
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020245 ()
A10-0118-22

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting S/W & Dongle, Comb (3 CH ECG & ABP), USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020238 ()
A10-0118-20

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting Software Dongle Only, 12 Channel ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020221 ()
A10-0118-12

  • Electrocardiographic long-term ambulatory recording analyser application software
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