BRAEBON Cable for Disposable RIP 8579

GUDID B14085790

Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByt

Braebon Medical Corporation

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

• Primary Device ID: B14085790
• NIH Device Record Key: e4e4015d-b31c-446b-a9d8-2907c83decc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAEBON Cable for Disposable RIP
• Version Model Number: 8579
• Catalog Number: 8579
• 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: 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: 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: 14 Inch
• Length: 14 Inch

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	B14085790 [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 Cable for Disposable RIP]

• B14085790: Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a meas
• B14005790: Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a meas
• B14085780: Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a meas
• B14005780: Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a meas
• B14005670: Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a meas