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 IDB146C1MA001010
NIH Device Record Keyb9f12b96-3333-4981-aabd-996fef5874d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMillennia Software
Version Model Number900-0618-00
Company DUNS049529118
Company NameBRAEMAR MANUFACTURING, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB146C1MA001010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-21
Device Publish Date2017-02-03

On-Brand Devices [Millennia Software]

B146C1MA051010The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in p
B146C1MA041010The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in p
B146C1MA031010The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in p
B146C1MA021010The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in p
B146C1MA011010The Millennia software system is indicated for: Cardiac evaluation of heart rate and rhythm in p
B146C1MA001010The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in
B146C4MA080900-0621-08
B146C4MA020900-0621-02
B146C4MA000900-0621-00
B146C3MA080900-0620-08
B146C3MA070900-0620-07
B146C3MA050900-0620-05
B146C3MA020900-0620-02
B146C3MA00900-0620-00
B146C2MA080900-0619-08
B146C2MA000900-0619-00
B146C1MA080900-0618-08
B146C1MA070900-0618-07

Trademark Results [Millennia Software]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MILLENNIA SOFTWARE
MILLENNIA SOFTWARE
90003572 not registered Live/Pending
Millennia SaaS, Inc.
2020-06-16

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