Q-RIP to Belt Controller Cable for Alice 8592A

GUDID B1408592A0

Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.

Braebon Medical Corporation

Pneumograph

• Primary Device ID: B1408592A0
• NIH Device Record Key: 4638df79-30ba-420f-ac05-e69917c71604
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-RIP to Belt Controller Cable for Alice
• Version Model Number: 8592A
• Catalog Number: 8592A
• 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
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com
• Phone: 613.831.6690
• Email: info@braebon.com

Device Dimensions

• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch
• Length: 48 Inch

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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	B1408592A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001743

FDA Product Code

• BZQ: Monitor, Breathing Frequency

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [Q-RIP to Belt Controller Cable for Alice]

• B1408592A0: Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measu
• B1400573A0: Cable for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disor