BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RESMED CORP

    Reg #: 3007573469 · FEI: 1000115734 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    RESMED CORP
    Registration Number
    3007573469
    FEI Number
    1000115734
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    9001 Spectrum Center Boulevard
    City
    San Diego
    State
    CA
    ZIP
    92123
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050359

    Owner / Operator

    Firm Name
    RESMED CORP.
    Operator Number
    9002319
    Address
    9001 Spectrum Center Blvd, --
    City
    San Diego
    State
    CA
    Postal Code
    92123
    Country
    US
    Correspondent
    David Lanfranchi

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD
    Generator, Oxygen, Portable CAW
    Support, Breathing Tube JAY
    Continuous, Ventilator, Home Use NOU
    Ventilator, Continuous, Facility Use CBK
    Ventilator, Continuous, Non-Life-Supporting MNS
    Sv70 Ventilator MNT
    Ventilatory Effort Recorder MNR
    Mask, Oxygen BYG
    Medical Device Data System OUG
    Disinfectant, Medical Devices LRJ
    Mask, Gas, Anesthetic BSJ
    Tubing, Pressure And Accessories BYX
    Protector, Skin Pressure FMP
    Sleeve, Limb, Compressible JOW
    Cabinet, Table And Tray, Anesthesia BRY
    Strap, Head, Gas Mask BTK
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Cannula, Nasal, Oxygen CAT

    Proprietary Names

    Air tubing connector SULLIVAN NASAL CPAP SYSTEM Nightowl Aria S8 CPAP System S8 VPAP System RPSII VPAP ST, H4i

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device