BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ICU Medical, Inc.

    Reg #: 1824231 · FEI: 1824231 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    ICU Medical, Inc.
    Registration Number
    1824231
    FEI Number
    1824231
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5700 W 23rd Ave
    City
    Gary
    State
    IN
    ZIP
    46406
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083641

    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

    Products

    Device Name Product Code
    Device, Fixation, Tracheal Tube CBH
    Tube Tracheostomy And Tube Cuff JOH
    Tube, Tracheostomy (W/Wo Connector) BTO
    Tube, Tracheal (W/Wo Connector) BTR
    Connector, Airway (Extension) BZA
    Balloon, Epistaxis EMX

    Proprietary Names

    DHD LONG TERM ENDOT BIVONA SECUREEASY Bivona Bivona® Aire-Cuf® Neonatal and Pediatric Tracheostomy Tubes Bivona Disconnect Wedge Bivona® Mid-Range Aire-Cuf® Adult Tracheostomy Tubes Bivona® Fome-Cuf® Tracheostomy Tubes Bivona® Fome-Cuf® Adult Tracheostomy Tubes with Talk Attachment MULTIPLE BIVONA MULTIPLE BIVONA (IFE) Bivona® Cuff Maintenance Device (CMD¿)open Bivona Hyperflex Bivona Adjustable Hyperflex Bivona® Uncuffed Neonatal and Pediatric FlexTend Plus Silicone Tracheostomy Tubes Bivona® Uncuffed Neonatal and Pediatric Tracheostomy Tubes MULTIPLE BIVONA ENDOTRACHEAL Ultraset Mount Adapter Duralife Portex Oxygen/Aerosol Adapters and Connectors (IFE) Portex Oxygen/Aerosol Tubing (IFE) Industrial - Connectors (IFE) Connector RESCAL Portex Fibre-Optic Bronchoscope Swivel Connector (IFE) Swivel Elbow CIRCUVENT Bivona® Aire-Cuf® Tracheostomy Tubes Bivona Sleep Apnea Tracheostomy Tube Epistaxis catheter

    Establishment Types

    Manufacture Medical Device