3100A HFOV 29028-012

GUDID 50190752159837

Flexible Patient Circuit w/Filter for 3100A (Box of 4)

VYAIRE MEDICAL, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 50190752159837
• NIH Device Record Key: cded297c-3930-4a0c-a79c-051b964ab81c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3100A HFOV
• Version Model Number: 29028-012
• Catalog Number: 29028-012
• 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	50190752159837 [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 [3100A HFOV]

• 10190752176577: FILTER 3100A
• 10190752155343: 3100A VENT,115V,60HZ,DOM RNT
• 10190752155336: 3100A VENT,115V,60HZ,DOM RFB
• 10190752155329: 3100A OSCILLATORY VENTILATOR
• 10190752155299: 3100A OSCILLATORY VENTILATOR
• 10190752155282: 3100A VENT, 220V, 50/60HZ
• 20190752148830: 3100A PATIENT CIRCUIT BODY
• 10190752155411: 3100A DISPOSABLES SHIP KIT (MR850 FLEX CIRCUIT)
• 10190752155404: 3100A DISPOSABLES SHIP KIT (MR730 FLEX CIRCUIT)
• 10190752155398: 3100A DISPOSABLES SHIP KIT (RIGID CIRCUIT)
• 50190752159844: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 50190752159837: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 50190752159820: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 50190752159790: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 50190752159783: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 50190752159776: Flexible Patient Circuit, 3100A MR730 in Heated Environment (Box of 4)
• 50190752159769: Flexible Patient Circuit, 3100A 380-88/ 400-00 in Non-Heated Environment (Box of 4)
• 50190752159752: Flexible Patient Circuit, 3100A 380-88/400-00 in Heated Environment (Box of 4)
• 50190752159738: Flexible Patient Circuit, 3100A MR730 in Non-Heated Environment (Box of 4)
• 50190752155495: Flexible Patient Circuit, 3100A, MR850 in Non-Heated Environment (Box of 4)
• 50190752155471: Flexible Patient Circuit, 3100A 380-88 in Non-Heated Environment (Box of 4)
• 50190752155464: Flexible Patient Circuit, 3100A 380-88/400-00 in Heated Environment (Box of 4)
• 50190752155457: Flexible Patient Circuit, 3100A 380-90 in Heated Environment (Box of 4)
• 50190752155433: Flexible Patient Circuit, 3100A, MR730 in Non-Heated Environment (Box of 4)
• 50190752155426: Flexible Patient Circuit, 3100A MR730 in Heated Environment (Box of 4)
• 50190752155266: Flexible Patient Circuit, 3100A 380-90 in Heated Environment (Box of 4)
• 50190752155259: Flexible Patient Circuit, 3100A MR850 in Non-Heated Environment (Box of 4)
• 50190752159745: Flexible Patient Circuit, 3100A MR850 in Heated Environment (Box of 4)
• 50190752155488: Flexible Patient Circuit, 3100A MR850 in Heated Environment (Box of 4)
• 50190752155143: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 50190752155136: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 50190752155129: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 50190752155112: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 50190752155105: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 50190752159912: Flexible Patient Circuit w/Filter for 3100A (Box of 4)
• 10190752201576: 3100A DISPOSABLES SHIP KIT (RIGID CIRCUIT)
• 10190752200760: 3100A DISPOSABLES SHIP KIT (MR730 FLEX CIRCUIT)
• 10190752200746: 3100A DISPOSABLES SHIP KIT (MR850 FLEX CIRCUIT)