BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ICU MEDICAL, INC.

    Reg #: 3013319212 · FEI: 3013319212 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    61
    Establishment Types
    2
    Classifications
    26

    Registration Details

    Registration Name
    ICU MEDICAL, INC.
    Registration Number
    3013319212
    FEI Number
    3013319212
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    600 N Field Dr
    City
    Lake Forest
    State
    IL
    ZIP
    60045
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080579

    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
    Cap, Device Disinfectant QBP
    Endoscopic Central Control Unit ODA
    Set, Administration, Intravascular FPA
    Catheter, Oximeter, Fiber-Optic DQE
    Catheter, Flow Directed DYG
    Probe, Thermodilution KRB
    Aid, Transfer IKX
    Pump, Infusion FRN
    Infusion Safety Management Software PHC
    Transducer, Blood-Pressure, Extravascular DRS
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Accessories, Pump, Infusion MRZ
    Set, I.V. Fluid Transfer LHI
    Hemodialysis Catheter Luer End Cap PEH
    Container, I.V. KPE
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Catheter, Intravascular, Diagnostic DQO
    Pump, Infusion, Pca MEA
    Catheter, Irrigation GBX
    Oximeter DQA
    Blood Pressure Cuff DXQ
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    System/Device, Pharmacy Compounding NEP
    Adaptor, Catheter GCE
    Tube, Aspirating, Flexible, Connecting BYY
    Tubing, Fluid Delivery FPK

    Proprietary Names

    Effective Cap Extension Set Advanced Sensor Catheter Decanting Set Plum Solo Precision IV Pump PLUM 360 Infusion System Sapphire Sets Primary Set Transpac IT Diana ChemoLock Transfer Set CLAVE Connector Catheter, Flow Directed Lifecare 5000 Infusion System Burette Set Sapphire Set Two-Way Transfer Device PLUM A+ Infusion System ClearGuard HD Antimicrobial barrier cap Additive Hinge Cap NovaCath ICU Medical MedNet Medication Management Suite Infusion Set Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 Cath Lab Kits Omni Flow Infusion System Dye Management System CVP Polyurethane Catheter W Heparin (No Balloon) Plum Duo Precision IV Pump Infusion Blood Set Nutrimix Empty Container Flow Directed Thermal-Dilution Infusion Sterile Empty Container PLUM XL Infusion System Plum DuoTM Infusion System Opticath Lifecare PCA Infusion system Irrigation Set Cogent Hemodynamic Monitoring System Infusion System SwabTip Male Disinfectant Cap LifeShield™ Infusion Safety Software Suite Blood Set Lifecare PCA Infusion System Vital Signs Wireless Monitoring System SwabCap Empty Container and Infusion Set Opticath, Heparin Coated PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter Diana Compounding Workflow System Diana Rio™ Drug Reconstitution Transfer Device ESP 60™Syringe Pump ADAPTOR, CATHETER Administration Sets: Primary Sets, Extension Sets, Burette Sets, Blood Sets Administration Set Catheter, oximeter, fiber-optic Gemstar Infusion Sets Infusion Pump System with Administration Set THORACENTESIS SET, 30 Inch ChemoLock ChemoPort

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198