BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ICU Medical, Inc.

    Reg #: 1219611 · FEI: 1219611 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    ICU Medical, Inc.
    Registration Number
    1219611
    FEI Number
    1219611
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    201 W Queen St
    City
    SOUTHINGTON
    State
    CT
    ZIP
    06489
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113700

    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
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Tube Tracheostomy And Tube Cuff JOH
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Piston FMF
    Syringe, Antistick MEG

    Proprietary Names

    ViaValve Jelco ViaValve Safety IV Catheter Bivona® Fome-Cuf® Tracheostomy Tubes Bivona Disconnect Wedge Pulsator Pro-Vent Line Draw Filter-Pro MULTIPLE BIVONA MULTIPLE BIVONA (IFE) Needle-Pro Edge Acuvance Acuvance Jelco Safety IV Catheter Bivona ViaValve Wing Jelco ViaValve-W Safety IV Catheter Bivona® Cuff Maintenance Device (CMD¿)open Bivona® Mid-Range Aire-Cuf® Adult Tracheostomy Tubes Bivona® Aire-Cuf® Tracheostomy Tubes PROTECTIV Jelco Jelco-W I.V. Catheter Cathlon Optiva Jelco ProtectIV-W Safety IV Catheter Jelco ProtectIV Plus-W Safety IV Catheter Bivona Hyperflex Bivona Adjustable Hyperflex

    Establishment Types

    Manufacture Medical Device