BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Neopuff T-piece infant resuscitator

    Reg #: 2085602 · FEI: 3000210616 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    K892885

    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, Emergency, Powered (Resuscitator) BTL

    Proprietary Names

    Neopuff T-piece infant resuscitator Resuscitation T-Piece Kit: Single use T-Piece Circuit-Classic Resuscitation T-Piece Kit: Single use T-Piece-Classic Resuscitation T-Piece Kit: Single use T-Piece-Classic with Mask 50mm Resuscitation T-Piece Kit: Humidified resuscitation system Resuscitation T-Piece Kit: Single use T-Piece-Classic with Mask 60mm

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198