BRAEBON Ultima Airflow Pressure Kit 0580-NOX

GUDID B1400580N1

Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains Pressure Sensor; Pneumo Flow Sensor; Dual 1 mm Keyhole to Keyhole Cable; Adapter Cable; Dual 1 mm Keyhole male to female cable.

Braebon Medical Corporation

Air/gas pressure transducer

• Primary Device ID: B1400580N1
• NIH Device Record Key: 6cbbe367-7a1d-4a28-b88c-c3d0a51a7021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAEBON Ultima Airflow Pressure Kit
• Version Model Number: 0580N
• Catalog Number: 0580-NOX
• 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
• 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

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
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1400580N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984431

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: 2026-03-16
• Device Publish Date: 2026-03-06

Devices Manufactured by Braebon Medical Corporation

• B1400580A1 - BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice: 2026-03-16 Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas)
• B1400580D1 - BRAEBON PT2 Dual Differntial Airflow Pressure Kit: 2026-03-16 Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas)
• B1400580N1 - BRAEBON Ultima Airflow Pressure Kit: 2026-03-16Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains Pressure Sensor; Pneumo Flow Sensor; Dual 1 mm Keyhole to Keyhole Cable; Adapter Cable; Dual 1 mm Keyhole male to female cable.
• B1400580N1 - BRAEBON Ultima Airflow Pressure Kit: 2026-03-16 Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas)
• B1400580PES1 - BRAEBON Ultima Esophageal Pressure Transducer: 2026-03-16 Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas)
• B14081110 - MediByte Patient Kit: 2025-05-12 Consumables to be used with the MediByte. The single-use kit contains: 8599 Oral + Nasal Cannula with Filter and Paper Tape.
• B14085990 - Oral + Nasal Cannula with Filter: 2025-05-12 Tubing used to detect airflow in sleep studies.
• B14003760 - BRAEBON Interface Cable for Alice 6: 2025-05-08 Cable for connecting sensors to a device.
• B1400580AXA0 - BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice: 2025-05-08 Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas)