BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vitera Mask Full Face Med/Lrg Sleep Lab

    Reg #: 2085602 · FEI: 3000210616 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FISHER & PAYKEL HEALTHCARE, INC.
    Registration Number
    2085602
    FEI Number
    3000210616
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17400 Laguna Canyon Road, #300
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    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

    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

    Complaint File Establishment per 21 CFR 820.198