BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ICU Medical, Inc.

    Reg #: 1526863 · FEI: 1526863 · Expires 2026
    View on FDA
    Products
    40
    Proprietary Names
    100
    Establishment Types
    3
    Classifications
    40

    Registration Details

    Registration Name
    ICU Medical, Inc.
    Registration Number
    1526863
    FEI Number
    1526863
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6250 Shier Rings Rd
    City
    DUBLIN
    State
    OH
    ZIP
    43016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181563

    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
    Introducer, Catheter DYB
    Catheter, Percutaneous DQY
    Syringe, Balloon Inflation MAV
    Spirometer, Therapeutic (Incentive) BWF
    Nebulizer (Direct Patient Interface) CAF
    Meter, Airway Pressure (Inspiratory Force) BXR
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Device, Fixation, Tracheal Tube CBH
    Transducer, Blood-Pressure, Extravascular DRS
    System/Device, Pharmacy Compounding NEP
    Exerciser, Non-Measuring ION
    Set, Administration, Intravascular FPA
    Filter, Infusion Line FPB
    Arterial Blood Sampling Kit CBT
    Stand, Infusion FOX
    Bag, Reservoir BTC
    Catheter Introducer Kit OFD
    Valve, Non-Rebreathing CBP
    Device, Cystometric, Hydraulic FEN
    Percussor, Powered-Electric BYI
    Device, Monitoring, Intracranial Pressure GWM
    Probe, Blood-Flow, Extravascular DPT
    Dressing Change Tray OXQ
    Tube, Tracheostomy (W/Wo Connector) BTO
    Injector And Syringe, Angiographic DXT
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Bottle, Collection, Breathing System (Calibrated) CBD
    Mask, Oxygen, Low Concentration, Venturi BYF
    Connector, Airway (Extension) BZA
    Stopcock, I.V. Set FMG
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Regulator, Pressure, Gas Cylinder CAN
    Enema Kit FCE
    Set, I.V. Fluid Transfer LHI
    Administrations Sets With Neuraxial Connectors PWH
    Needle, Hypodermic, Single Lumen FMI
    Peripheral Catheter Insertion Kit OWL
    Infusor, Pressure, For I.V. Bags KZD
    Filter, Bacterial, Breathing-Circuit CAH

    Proprietary Names

    Medflator II DHD Cliniflo® Low Flow Exerciser DHD CliniFlo EASIVENT NIF-TEE NIF KIT RESCAL Portex 1st Response Adult Manual Resuscita PEEP Valve Exhalation filter DHD LONG TERM ENDOT BIVONA SECUREEASY Thera-Mist NovaTrans(R) Medex Tubing Connectors & Stopcocks EXERCISER INSPIRATORY MUSCLE TRAINER KIT injection adapter Stealth Medex Various IV administration sets KidsKit (R) Secure (R) various clamps and brackets RESERVOIR BAG Flo2 Anesthesia Breathing Bag FACEPLATE PALM CUP PERCUSSOR Portex Flo-Mist TranStar (R) TranStar Portex Blue Line Ultra Tracheostomy Kit Suctionaid Portex Blue Line Ultra Suctionaid Trachostomy Tube Kits BL Ultra Suctionaid Change Kits Blue Line Ultra Suctionaid ACE Low pressure ext. tubing High pressure ext. tubing AsthmaKit Medex Bacterial Filter VACON OXYPEEP FLO2 First breath Ultraset Mount Adapter Duralife Portex Oxygen/Aerosol Adapters and Connectors (IFE) Portex Oxygen/Aerosol Tubing (IFE) Industrial - Connectors (IFE) Connector Portex Fibre-Optic Bronchoscope Swivel Connector (IFE) Swivel Elbow CIRCUVENT MEDEX STOPCOCK & LUER LOCK PLUG IV admin set with minicheck valve Pneupac paraPAC plus Disposable CPAP Circuit Pneupac paraPAC plus PRESSURE REGULATOR GAS CYLINDER TUBING CONNECTOR (OXYGEN FLOWMETER REGULATOR CONNECTOR) TheraPEP LogiCal(R) Nu-site SmartSite Shiels Intussuception Air Red. Sys. ACAPELLA CHOICE DH DUET DM AEROPHARM CADD® Yellow Medication Cassette Reservoir with NRFit™ connector Female Yellow Cap with NRFit™ connector Male Yellow Cap with NRFit™ connector CADD® Yellow Extension Sets with NRFit™ connector CADD® Yellow Administration Set with NRFit™ connector CADD® Filling Adapter with male NRFit™ connector and female Luer CADD® Infusion Adapter with male NRFit™ connector and female Luer Blood transfer device SmartSite Anesthesia stopcock EzPAP Coach 2 SmartSite T- Connector Miniloop Mini-vol extension set Small Bore Stopcocks CLEAR CUFF C-FUSOR Gauge Guard BREATHING-CIRCUIT BACTERIAL FILTER

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device