Bellavista

GUDID 10190752188921

Diagnostic Package Capnography Sidestream

VYAIRE MEDICAL, INC.

Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor Respiration monitor

• Primary Device ID: 10190752188921
• NIH Device Record Key: 1e3e0aa3-dca1-4a34-a992-091eb38336d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bellavista
• Version Model Number: 302.323.000
• Company DUNS: 080456871
• Company Name: VYAIRE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 20 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752188921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183364

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 2024-01-04
• Device Publish Date: 2023-12-27

On-Brand Devices [Bellavista]

• 70190752148880: Exhalation Valve
• 50190752197709: Adult and pediatric ventilator
• 50190752197662: Adult and pediatric ventilator
• 10190752188921: Diagnostic Package Capnography Sidestream
• 10190752188853: Diagnostic Package Capnography Mainstream