PureFlow OroNasal Cannula + Filter 8596-50

GUDID B1408596501

Tubing used to detect airflow in sleep studies.

Braebon Medical Corporation

Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use

• Primary Device ID: B1408596501
• NIH Device Record Key: 2fb60e29-11ed-45f8-976e-c95116ea8345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureFlow OroNasal Cannula + Filter
• Version Model Number: 8596-50
• Catalog Number: 8596-50
• Company DUNS: 251731105
• Company Name: Braebon Medical Corporation
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14085960 [Unit of Use]
HIBCC	B1408596501 [Primary]

FDA Product Code

• CAT: Cannula, Nasal, Oxygen

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: 2019-11-18
• Device Publish Date: 2019-11-08

On-Brand Devices [PureFlow OroNasal Cannula + Filter]

• B1400597501: Tubing used to detect airflow in sleep studies.
• B1408597501: Tubing used to detect airflow in sleep studies.
• B140859951: Tubing used to detect airflow in sleep studies.
• B1408596501: Tubing used to detect airflow in sleep studies.