BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    PORTEX ULTRAPERC

    Reg #: 3012542015 · FEI: 3012542015 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ICU Medical Nederland B.V.
    Registration Number
    3012542015
    FEI Number
    3012542015
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bijsterhuizen 22 - 08
    City
    Wijchen Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K041348

    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 And Tube Cuff JOH

    Proprietary Names

    PORTEX ULTRAPERC Portex Blue Line Ultra® tracheostomy tubes Portex ULTRAperc tracheostomy apparatus and instruments Portex Percutaneous Dilation Tracheostomy Kit

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device