BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    FISHER & PAYKEL HEALTHCARE S.A.DE C.V.

    Reg #: 3015928685 · FEI: 3015928685 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    37
    Establishment Types
    2
    Classifications
    8

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    Registration Details

    Registration Name
    FISHER & PAYKEL HEALTHCARE S.A.DE C.V.
    Registration Number
    3015928685
    FEI Number
    3015928685
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Blvd La Encantada #24352 Int. A, Fideicomiso El Florido
    City
    Tijuana, Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K211560

    Owner / Operator

    Firm Name
    FISHER & PAYKEL HEALTHCARE NZ LTD
    Operator Number
    8040217
    Address
    15 MAURICE PAYKEL PLACE
    City
    EAST TAMAKI, AUCKLAND
    State
    NZ-NOTA
    Postal Code
    2013
    Country
    NZ
    Correspondent
    Brian Schultz

    US Agent

    Business Name
    FISHER & PAYKEL LIMITED HEALTHCARE
    Contact Name
    Diego Vargas Banuelos
    Address
    17400 Laguna Canyon Road., SUITE 300, Irvine
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 4341005

    Products

    Device Name Product Code
    Tape And Bandage, Adhesive KGX
    High Flow/High Velocity Humidified Oxygen Delivery Device QAV
    Ventilator, Non-Continuous (Respirator) BZD
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Cannula, Nasal, Oxygen CAT
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Nebulizer (Direct Patient Interface) CAF
    Noninvasive Positive Airway Pressure System, Facility Use SGR

    Proprietary Names

    DaisyDot Sensor Cover DaisyDot Mini Sensor Cover Optiflow Junior 2 WigglewiNG XS S Optiflow Junior 2 WigglewiNG XXL Optiflow Junior 2 WigglewiNG M L XL Airvo 3 F&P Nova Micro PIllows Mask F&P Nova Micro AirSpiral Heated Breathing Tube Optiflow Patient Interface MR850 Respiratory Humidifier F&P Evora Full Mask myAirvo Optiflow Nasal cannula large Nasal cannula small Nasal cannula medium Optiflow+ nasal cannula Nasal cannula extra large Nasal cannula extra small RT oxygen cannula Optiflow oxygen cannula BC oxygen cannula Infosmart Software package MR850 Resipiratory Humidifier F&P 950 Respiratory Humidifier F&P 950 MR290 Humidification Chamber F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling Optiflow Trace F&P 950 Bubble CPAP Breathing Circuit Kits F&P Evora Nasal Mask Infant Evaqua 2 (RT265/RT266) Airvo Nebulizer Adapter OptiPAP Junior Optiflow Junior 2/2+ Interface Range Optiflow Asymmetric Interface

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device