BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Vitera Mask Full Face Med/Lrg Sleep Lab

    Reg #: 3008264065 · FEI: 3008264065 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Fisher & Paykel Healthcare S.A.de C.V.
    Registration Number
    3008264065
    FEI Number
    3008264065
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Av. Todos los Santos #12831, Parque Industrial Pacifico
    City
    Tijuana Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K190713

    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
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Vitera Mask Full Face Med/Lrg Sleep Lab Vitera Mask Full Face Small Sleep Lab Vitera Mask Fitpack Sml/Med/Lrg A Model Vitera Mask Full Face Large Sleep Lab Vitera Mask Full Face Small A Model Vitera Mask Dbl Seal Med/Med A Model Vitera Mask Dbl Seal Sml/Sml A Model Vitera Mask Full Face Medium A Model Vitera Mask Full Face Medium Sleep Lab Vitera Mask Dbl Seal Lrg/Lrg A Model Vitera Mask Full Face Large A Model Vitera Mask myStart Pack Sml/Med/Lrg A Model

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)