BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VYAIRE MEDICAL, INC.

    Reg #: 3013421741 · FEI: 3013421741 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    VYAIRE MEDICAL, INC.
    Registration Number
    3013421741
    FEI Number
    3013421741
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    26125 North Riverwoods Blvd
    City
    Mettawa
    State
    IL
    ZIP
    60045
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051767
    PMA Number
    P890057

    Owner / Operator

    Firm Name
    Vyaire Medical
    Operator Number
    10053153
    Address
    26125 North Riverwoods Blvd
    City
    Mettawa
    State
    IL
    Postal Code
    60045
    Country
    US

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK
    Mixer, Breathing Gases, Anesthesia Inhalation BZR
    Support, Breathing Tube JAY
    Battery, Replacement, Rechargeable MOQ
    Ventilator, High Frequency LSZ
    Cable ISN
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Ventilator, Non-Continuous (Respirator) BZD
    Cannula, Nasal, Oxygen CAT

    Proprietary Names

    LTV1150 LTV2 LTV 2200 Heliox Low Flow Sentry Blender Infant Flow LTV 1000 Breathing Circuits LTV2 Accessory/Component LTV 1200 Ventilator 3100 High Frequency Oscillating Ventilator LTV 1200 MR LTV Series Ventilator LTV Series bellavista iFlow Infant Flow SiPAP Avea Ventilator

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198