Ultima Dual Pressure Sensor. 0585

GUDID B14005850

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.

Braebon Medical Corporation

Air/gas pressure transducer

• Primary Device ID: B14005850
• NIH Device Record Key: 5356f466-795c-47fb-8e16-acc2042efc62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultima Dual Pressure Sensor.
• Version Model Number: 0585
• Catalog Number: 0585
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14005850 [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: 2019-11-15
• Device Publish Date: 2019-11-07

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