BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Mallinckrodt Dar S.r.l.

    Reg #: 9680661 · FEI: 3002808696 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    Mallinckrodt Dar S.r.l.
    Registration Number
    9680661
    FEI Number
    3002808696
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA G.BOVE, 2/4/6/8
    City
    MIRANDOLA Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K942392

    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
    Medtronic formerly Covidien
    Contact Name
    Kae Miller
    Address
    6135 Gunbarrel Ave
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US
    Email
    [email protected]
    Phone
    303 4081427

    Products

    Device Name Product Code
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Connector, Airway (Extension) BZA
    Airway, Oropharyngeal, Anesthesiology CAE
    Catheters, Suction, Tracheobronchial BSY
    Filter, Bacterial, Breathing-Circuit CAH
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Tube, Tracheostomy (W/Wo Connector) BTO
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Ventilator, Continuous, Facility Use CBK
    Mask, Gas, Anesthetic BSJ

    Proprietary Names

    breathing circuit Male to male adapter Y PIECE) Airway Connector with Flex Tube Guedel Airway Ty-Care/Ty-Care Exel Closed S ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT Barrierbac Barrierbac S Hygroster HME for Tracheostomized Patients Tracheolife SSV Phonate Shiley Speaking Valve Flexlife Hygrolife MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT Spirobac (& Adapters) Speaking Valve with Oxygen Port SSVO Sterivent Sterivent S Hygrobac Hybrobac S Hygrobaby Hygroboy Puritan Bennett 980 Series Ventilator System Anesthesia Face Mask

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)