BRAEBON Ultima Body Position Sensor 0531

GUDID B14005310

Five-position sensor to accurately record body position during sleep studies.

Braebon Medical Corporation

Patient positioning sensor Patient positioning sensor

• Primary Device ID: B14005310
• NIH Device Record Key: db6ff9f3-cbf9-4b87-8664-856c0a5a7c5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAEBON Ultima Body Position Sensor
• Version Model Number: 0531
• Catalog Number: 0531
• 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: false
• 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 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14005310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981969

FDA Product Code

• LEL: Device, Sleep Assessment

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 Ultima Body Position Sensor]

• B14005320: Five-position sensor to accurately record body position during sleep studies.
• B14005310: Five-position sensor to accurately record body position during sleep studies.
• B1400530M0: Five-position sensor to accurately record body position during sleep studies.
• B14005300: Five-position sensor to accurately record body position during sleep studies.