3100 HFOV 12152

GUDID 50190752148879

Expiratory Filter for Patient Circuit

VYAIRE MEDICAL, INC.

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• Primary Device ID: 50190752148879
• NIH Device Record Key: 840fb8d8-2def-45f0-8d52-170b45a079e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3100 HFOV
• Version Model Number: 12152
• Catalog Number: 12152
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752148871 [Primary]
GS1	50190752148879 [Package]; Contains: 10190752148871; Package: Case [25 Units]; In Commercial Distribution

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: 2021-03-15
• Device Publish Date: 2021-03-05

On-Brand Devices [3100 HFOV]

• 10190752181472: CIRCUIT PORT ADAPTER FOR GAS SAMPLING
• 10190752160804: MICROBLENDER,W/2'/3' H,H/L,HFOV
• 10190752158900: Tube Set, Filtered Patient Circuit
• 10190752158894: Tube Set, Non-Filtered Patient Circuit
• 10190752158733: EXHALED GAS DEFLECTOR
• 10190752155381: Scavenger for 3100A / 3100B High Frequency Oscillatory Ventilators
• 10190752176218: RETAINER PWR CORD INSTRUMENT
• 10190752155213: KIT, 3100 BLENDER BRACKET
• 50190752148879: Expiratory Filter for Patient Circuit
• 50190752148855: Inspiratory Filter for Patient Circuit