Millennia Software - The Millennia Software system is indicated for: - BRAEMAR MANUFACTURING, LLC

Duns Number:049529118

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

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More Product Details

Catalog Number

-

Brand Name

Millennia Software

Version/Model Number

900-0618-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K024323

Product Code Details

Product Code

MLO

Product Code Name

Electrocardiograph, Ambulatory, With Analysis Algorithm

Device Record Status

Public Device Record Key

b9f12b96-3333-4981-aabd-996fef5874d6

Public Version Date

October 21, 2019

Public Version Number

4

DI Record Publish Date

February 03, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BRAEMAR MANUFACTURING, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 122