BRAEBON Ultima Airflow Sensor, Pediatric 0510PED

GUDID B1400510PED0

Thermistor airflow sensor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording onto a data ac

Braebon Medical Corporation

General-purpose patient temperature probe, reusable

• Primary Device ID: B1400510PED0
• NIH Device Record Key: e3b00e80-a411-43f9-bc70-1c41731cf243
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAEBON Ultima Airflow Sensor, Pediatric
• Version Model Number: 0510PED
• Catalog Number: 0510PED
• 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: 6138316690
• Email: info@braebon.com
• Phone: 6138316690
• Email: info@braebon.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1400510PED0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981445

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

Devices Manufactured by Braebon Medical Corporation

• B14086201200 - BRAEBON Leadwire Kit: 2024-09-23 Leads for connecting electrodes to a PSG.
• B1408620600 - BRAEBON Leadwire Kit: 2024-09-23 Leads for connecting electrodes to a PSG.
• B1408620720 - BRAEBON Leadwire Kit: 2024-09-23 Leads for connecting electrodes to a PSG.
• B1400532XA0 - BRAEBON Ultima Body Position Sensor: 2024-07-22 Five-position sensor to accurately record body position during sleep studies.
• B1400533XA0 - BRAEBON Ultima Body Position Sensor for Alice 5: 2024-07-22 Five-position sensor to accurately record body position during sleep studies.
• B140BM55940 - Divided Nasal Cannula: 2024-07-22 Tubing used to detect airflow in sleep studies.
• B1400514A0 - BRAEBON cTherm Cannula Thermistor for Alice PDX: 2024-04-02 Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording
• B1400572A0 - BRAEBON Q-RIP Belt for Alice: 2024-04-02 Belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respi