BRAEBON Disposable RIP Belt, Large 5573-24

GUDID B1405573241

Disposable belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The s

Braebon Medical Corporation

Pneumograph

• Primary Device ID: B1405573241
• NIH Device Record Key: 79c96f9b-37b1-49c0-bd60-807e38d8699d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAEBON Disposable RIP Belt, Large
• Version Model Number: 5573-24
• Catalog Number: 5573-24
• Company DUNS: 251731105
• Company Name: Braebon Medical Corporation
• Device Count: 24
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Dimensions

• Length: 39 Inch
• Length: 39 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14055730 [Unit of Use]
HIBCC	B1405573241 [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: 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 Disposable RIP Belt, Large]

• B1405573241: Disposable belt intended for use during sleep disorder studies as a measure of respiratory effo
• B14055710: Disposable belt intended for use during sleep disorder studies as a measure of respiratory effo