BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Mallinckrodt Medical

    Reg #: 8020889 · FEI: 3003382061 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    30
    Establishment Types
    4
    Classifications
    7

    Registration Details

    Registration Name
    Mallinckrodt Medical
    Registration Number
    8020889
    FEI Number
    3003382061
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CORNAMADDY
    City
    ATHLONE Westmeath
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K051416

    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
    200 Medtronic Drive
    City
    Lafayette
    State
    CO
    ZIP
    80026
    Country
    US
    Email
    [email protected]
    Phone
    303 4081427

    Products

    Device Name Product Code
    Tube Tracheostomy And Tube Cuff JOH
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Stylet, Tracheal Tube BSR
    Tube, Tracheostomy (W/Wo Connector) BTO
    Tube, Tracheal (W/Wo Connector) BTR
    Tube, Bronchial (W/Wo Connector) BTS
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ

    Proprietary Names

    Shiley Extended XLT BronchoCath with CPAP Shiley™ STYLET, TRACHEAL TUBE Shiley Adult Flexible EVAC Tracheostomy Tube with TaperGuard Cuff SealGuard Evac Tracheal Tubes SealGuard Tracheal Tubes BronchoCath Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115- XXOR) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119- XXNR) Tube, tracheal Infusion Catheter Cragg-McNamara Valved Infusion Catheter Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Safety Flex Shiley Adult Trach. Tubes & Access. LaserFlex Shiley Shiley™ Adult Flexible Disposable Inner Cannula XLT Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula

    Establishment Types

    Manufacture Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer) Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)