BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    BL Ultra Suctionaid Change Kits

    Reg #: 9617604 · FEI: 3002558692 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ICU Medical Healthcare Manufacturing S.A. de C.V.
    Registration Number
    9617604
    FEI Number
    3002558692
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AVENIDA CALIDAD No 14409, Parque Industrial Internacional Tijuana
    City
    Tijuana, B.C. C.P. Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K030570

    Owner / Operator

    Firm Name
    ICU Medical, Inc.
    Operator Number
    8020727
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Michelle Doherty

    US Agent

    Business Name
    ICU Medical, Inc.
    Contact Name
    Michelle Doherty
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    ZIP
    92673
    Country
    US
    Email
    [email protected]
    Phone
    949 3706562

    Products

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

    Proprietary Names

    BL Ultra Suctionaid Change Kits Blue Line Ultra Suctionaid Portex Blue Line Ultra Suctionaid Trachostomy Tube Kits Portex Blue Line Ultra Tracheostomy Kit Suctionaid

    Establishment Types

    Manufacture Medical Device