BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    RT280, 'Adult Evaqua 2' Dual Heated Breathing Circuit

    Reg #: 9611451 · FEI: 3002806988 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FISHER & PAYKEL HEALTHCARE, LTD.
    Registration Number
    9611451
    FEI Number
    3002806988
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15 MAURICE PAYKEL PLACE
    City
    EAST TAMAKI Auckland
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K122432

    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
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE

    Proprietary Names

    RT280, 'Adult Evaqua 2' Dual Heated Breathing Circuit RT302 MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow+ Nasal Cannula RT481 Care Continuum Kit- Vent Use RT232, 'Adult Optiflow Circuit Kit with MicroCell Technology RT332, 'MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow Nasal Cannula' RT380 and RT385, 'Adult Evaqua 2' Dual Heated Breathing Circuits

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device