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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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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 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 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 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 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
ARCS Analysis & Reporting Software & Dongle, 3 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020177 ()
A10-0118-00

  • Electrocardiographic long-term ambulatory recording analyser application software
CB Series Analysis & Reporting S/W - 3 & 12 CH ECG & Combined ABPM
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020160 ()
A10-0036

  • Electrocardiographic long-term ambulatory recording analyser application software
CB Series Analysis & Reporting S/W - 3 CH ECG & Combined ABPM
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020153 ()
A10-0035

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

  • 00817980020146 ()
A10-0032

  • Electrocardiographic long-term ambulatory recording analyser application software
CB Series Analysis & Reporting Software - 3 & 12 CH ECG
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020139 ()
A10-0031

  • 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 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, 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, 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, 12 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020214 ()
A10-0118-10

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

  • 00817980020207 ()
A10-0118-02

  • 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
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 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
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
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSERV-6AA-XXXXA
In Commercial Distribution

  • 00812345029857 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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