Millennia Software

GUDID B146C1MA080

BRAEMAR MANUFACTURING, LLC

Electrocardiographic long-term ambulatory recording analyser application software

• Primary Device ID: B146C1MA080
• NIH Device Record Key: 1907c385-3e3b-4c6b-a4a2-99bc1b47976b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Millennia Software
• Version Model Number: 900-0618-08
• 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	B146C1MA080 [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: 2
• Public Version Date: 2019-10-21
• Device Publish Date: 2019-10-09

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