BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Phonate Shiley Speaking Valve

    Reg #: 3023294726 · FEI: 3023294726 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Mallinckrodt Dar S.r.l.
    Registration Number
    3023294726
    FEI Number
    3023294726
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unita locale via Caboto 38/40
    City
    Reggiolo (RE) Reggio Emilia
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K945406

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    US Agent

    Business Name
    COVIDIEN LLC
    Contact Name
    Kae Miller
    Address
    6165 Gunbarrel Ave
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US
    Email
    [email protected]
    Phone
    303 4081427

    Products

    Device Name Product Code
    Tube, Tracheostomy (W/Wo Connector) BTO

    Proprietary Names

    Phonate Shiley Speaking Valve SSV

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)