Millennia Software

GUDID B146C1MA001010

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

Electrocardiographic long-term ambulatory recording analyser application software

• Primary Device ID: B146C1MA001010
• NIH Device Record Key: b9f12b96-3333-4981-aabd-996fef5874d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Millennia Software
• Version Model Number: 900-0618-00
• Company DUNS: 049529118
• Company Name: BRAEMAR MANUFACTURING, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B146C1MA001010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024323

FDA Product Code

• MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-21
• Device Publish Date: 2017-02-03

On-Brand Devices [Millennia Software]

• B146C1MA051010: The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in p
• B146C1MA041010: The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in p
• B146C1MA031010: The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in p
• B146C1MA021010: The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in p
• B146C1MA011010: The Millennia software system is indicated for: Cardiac evaluation of heart rate and rhythm in p
• B146C1MA001010: The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in
• B146C4MA080: 900-0621-08
• B146C4MA020: 900-0621-02
• B146C4MA000: 900-0621-00
• B146C3MA080: 900-0620-08
• B146C3MA070: 900-0620-07
• B146C3MA050: 900-0620-05
• B146C3MA020: 900-0620-02
• B146C3MA00: 900-0620-00
• B146C2MA080: 900-0619-08
• B146C2MA000: 900-0619-00
• B146C1MA080: 900-0618-08
• B146C1MA070: 900-0618-07