3100B HFOV 29028-019

GUDID 50190752159899

Flexible Patient Circuit w/Filter for 3100B (FP850)

VYAIRE MEDICAL, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 50190752159899
• NIH Device Record Key: 1a96d266-71b4-4859-9d8e-1a2fce592231
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3100B HFOV
• Version Model Number: 29028-019
• Catalog Number: 29028-019
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
• 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
• 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	50190752159899 [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: 2021-05-13
• Device Publish Date: 2021-05-05

On-Brand Devices [3100B HFOV]

• 10190752158993: Flexible Patient Circuit w/Filter for 3100B (FP850)
• 10190752158627: 3100B VENT ASSY, DOMESTIC
• 10190752155442: 3100B VENT ASSY,220V/50HZ
• 50190752159905: Flexible Patient Circuit w/Filter for 3100B (HRCI)
• 50190752159899: Flexible Patient Circuit w/Filter for 3100B (FP850)
• 50190752159882: Flexible Patient Circuit w/Filter for 3100B (FP730)
• 50190752159875: 3100B Disposables Kit, Box of 4 / HRC
• 50190752159868: 3100B Disposables Kit, Box of 4 / F&P 850
• 50190752159851: 3100B Disposables Kit, Box of 4 / F&P 730
• 50190752158915: 3100B Disposables Kit, Box of 4 / HRC
• 50190752157567: 3100B Disposables Kit, Box of 4 / F&P 850
• 50190752155150: 3100B Disposables Kit, Box of 4 / F&P 850
• 10190752158825: 3100B Disposable Items Kit / F&P 850
• 10190752158818: 3100B Disposable Items Kit / F&P 730
• 10190752158801: 3100B Disposable Items Kit / HRCI
• 50190752159004: Flexible Patient Circuit w/Filter for 3100B (HRCI)
• 50190752158984: Flexible Patient Circuit w/Filter for 3100B (FP730)