DEVICE: Millennia Software (B146C1MA021010)
Device Identifier (DI) Information
Millennia Software
900-0618-02
In Commercial Distribution
BRAEMAR MANUFACTURING, LLC
900-0618-02
In Commercial Distribution
BRAEMAR MANUFACTURING, LLC
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 Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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41651 | Electrocardiographic long-term ambulatory recording analyser application software |
A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K024323 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a77620ea-fa2b-423a-af0c-bbfd4ff7ca5e
October 21, 2019
4
February 03, 2017
October 21, 2019
4
February 03, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined