Bellavista 301.100.130

GUDID 50190752197709

Adult and pediatric ventilator

VYAIRE MEDICAL, INC.

Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator

• Primary Device ID: 50190752197709
• NIH Device Record Key: 60137d26-57f5-447f-804c-db9f7a3e537e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bellavista
• Version Model Number: 301.100.130
• Catalog Number: 301.100.130
• 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: 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: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com
• Phone: 8333273284
• Email: customersupport@vyaire.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752197701 [Primary]
GS1	50190752197709 [Package]; Contains: 10190752197701; Package: Case [1 Units]; In Commercial Distribution

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: 2022-10-21
• Device Publish Date: 2022-10-13

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