BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    TRUDELL MEDICAL INTERNATIONAL

    Reg #: 9612777 · FEI: 3001610754 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    TRUDELL MEDICAL INTERNATIONAL
    Registration Number
    9612777
    FEI Number
    3001610754
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    725 Baransway Drive
    City
    LONDON Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K090065

    Owner / Operator

    Firm Name
    TRUDELL MEDICAL INTERNATIONAL
    Operator Number
    8020351
    Address
    725 Baransway Drive,
    City
    LONDON
    State
    Ontario
    Postal Code
    N5V 5G4
    Country
    CA
    Correspondent
    Marianne Tanton

    US Agent

    Business Name
    MONAGHAN MEDICAL CORP.
    Contact Name
    Janice Breen
    Address
    153 Industrial Blvd.
    City
    PLATTSBURGH
    State
    NY
    ZIP
    12901
    Country
    US
    Email
    [email protected]
    Phone
    518 6348149

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF
    Meter, Peak Flow, Spirometry BZH
    Compressor, Air, Portable BTI
    Holding Chambers, Direct Patient Interface NVP
    Spirometer, Therapeutic (Incentive) BWF
    Mask, Oxygen BYG
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ

    Proprietary Names

    AeroChamber mini Aerosol Chamber AeroChamber mini Holding Chamber TruZone Peak Flow Meter RespiConnect Adapter MC 300 Nebulizer AeroEclipse II BAN Nebulizer MC 300*R Nebulizer Ombra Table Top Compressor AeroChamber2go Anti-Static Valved Holding Chamber AeroChamber Plus Z Stat aVHC Filter Kit (Accessory to BAN Nebulizers) VersaPAP* Positive Airway Pressure (PAP) Device MASK ASSEMBLY RespiChamber Valved Holding Chamber AeroChamber* MV Holding Chamber Aerobika OPEP with Manometer Aerobika Oscillating Positive Expiratory Pressure Device AeroChamber Plus Flow-Vu aVHC AeroTrach Plus anti-static Valved Holding Chamber Corrugated tube with mouthpiece accessory AeroEclipse XL BAN Nebulizer

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility