BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ICU MEDICAL, INC

    Reg #: 1713468 · FEI: 1713468 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    56
    Establishment Types
    4
    Classifications
    28

    Registration Details

    Registration Name
    ICU MEDICAL, INC
    Registration Number
    1713468
    FEI Number
    1713468
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4455 ATHERTON DR.
    City
    Salt Lake City
    State
    UT
    ZIP
    84123
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080077

    Owner / Operator

    Firm Name
    ICU MEDICAL, INC.
    Operator Number
    2025816
    Address
    951 Calle Amanecer, --
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Michelle Doherty

    Products

    Device Name Product Code
    Stopcock, I.V. Set FMG
    Set, I.V. Fluid Transfer LHI
    Cap, Device Disinfectant QBP
    Transducer, Blood-Pressure, Extravascular DRS
    Catheter, Intravascular, Diagnostic DQO
    Set, Administration, Intravascular FPA
    Catheter, Straight EZD
    Accessories, Catheter, G-U KNY
    Catheter, Multiple Lumen GBP
    Catheter, Continuous Flush KRA
    System/Device, Pharmacy Compounding NEP
    Catheter, Flow Directed DYG
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Catheter, Oximeter, Fiber-Optic DQE
    Accessories, Catheter KGZ
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Arterial Blood Sampling Kit CBT
    Infusor, Pressure, For I.V. Bags KZD
    Probe, Thermodilution KRB
    Oximeter DQA
    Blood Pressure Cuff DXQ
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Tubes, Gastrointestinal (And Accessories) KNT
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Pump, Infusion FRN
    Hemodialysis Catheter Luer End Cap PEH
    Container, I.V. KPE

    Proprietary Names

    CLAVE Stopcock SwabCap Expressions MR Transpac IV Cardiac Catheterization Kit Smartvalve Graduated Adapter With CLAVE CVP CATHETER Pull Tab Squeeze Flush ChemoCLAVE Prep System Diana Compounding Workflow System Diana Antimicrobial CLAVE Opticath, Heparin Coated High Pressure Tubing Safeset TriOX OPTICATH® CENTRAL VENOUS OXIMETRY CATHETER Spiros Neutron Transpac IT ChemoLock ChemoPort Diana ChemoLock Transfer Set Vital Signs Wireless Monitoring System Spinning Spiros SHIELDED BLUNT CANNULA PRESSURE INFUSION CUFF Advanced Sensor Catheter Dye Management System Cogent Hemodynamic Monitoring System High Pressure Sets Syringe Adaptor CLAVE Connector Single Lead Dispensing Set Opticath Catheter, oximeter, fiber-optic CVP Polyurethane Catheter W Heparin (No Balloon) Lopez Valve Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 Thermoset RECEPTAL LINER SwabTip Male Disinfectant Cap Accudynamic PharmAssist Stopcock Extension Sets Clave Neutral-Displacement Needlefree Connectors Flow Directed Thermal-Dilution Infusion ESP 60™Syringe Pump PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter Catheter, Flow Directed ClearGuard HD Antimicrobial barrier cap Additive Hinge Cap SetSource Ext Sets Primary IV Set Disposable Transducer Monitoring Kits

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)