BRAEBON MediByte MP8KN

GUDID B140MP8KN0

The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical

Braebon Medical Corporation

Polysomnograph

• Primary Device ID: B140MP8KN0
• NIH Device Record Key: 2ed5350c-6b40-4bd2-832b-1af125b21e50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAEBON MediByte
• Version Model Number: MP8KN
• Catalog Number: MP8KN
• Company DUNS: 251731105
• Company Name: Braebon Medical Corporation
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B140MP8KN0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061764

FDA Product Code

• MNR: Ventilatory Effort Recorder

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [BRAEBON MediByte ]

• B140MP8WN0: The MediByte is a portable sleep data recorder used to record physiological signals during sleep
• B140MP8W0: The MediByte is a portable sleep data recorder used to record physiological signals during sleep
• B140MP8U0: The MediByte is a portable sleep data recorder used to record physiological signals during sleep
• B140MP8KN0: The MediByte is a portable sleep data recorder used to record physiological signals during sleep
• B140MP8KLITE0: The MediByte is a portable sleep data recorder used to record physiological signals during sleep
• B14088900: Cable to connect MediByte to a computer for configuration and data upload.