BRAEMAR MANUFACTURING, LLC

Address:1285 Corporate Center Dr Ste 150,EAGAN,MN,55121,US

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- Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The Millennia Software system is indicated for: Cardiac evaluation of heart rat 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.

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The Millennia software system is indicated for:Cardiac evaluation of heart rate 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.

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The Millennia Software system is indicated for:Cardiac evaluation of heart rate 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.

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The Millennia Software system is indicated for:Cardiac evaluation of heart rate 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.

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The Millennia Software system is indicated for:Cardiac evaluation of heart rate 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.

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1