3100A/B HFOV 766897

GUDID 10190752148840

3100A/B BELLOWS / WATER TRAP

VYAIRE MEDICAL, INC.

Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator

• Primary Device ID: 10190752148840
• NIH Device Record Key: 5b0d1a30-eeb0-4ce7-af55-db1277e32ab2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3100A/B HFOV
• Version Model Number: 766897
• Catalog Number: 766897
• Company DUNS: 080456871
• Company Name: VYAIRE MEDICAL, INC.
• 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: 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: +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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752148840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890057

FDA Product Code

• LSZ: VENTILATOR, HIGH 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: 2021-11-16
• Device Publish Date: 2021-11-08

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• 10190752188921 - Bellavista: 2024-01-04 Diagnostic Package Capnography Sidestream