BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ICU MEDICAL, INC.

    Reg #: 2025816 · FEI: 2025816 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    ICU MEDICAL, INC.
    Registration Number
    2025816
    FEI Number
    2025816
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    951 CALLE AMANECER
    City
    SAN CLEMENTE
    State
    CA
    ZIP
    92673
    Country
    US

    Regulatory Submissions

    510(k) Number
    K791796

    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
    Container, I.V. KPE
    Set, I.V. Fluid Transfer LHI
    Syringe, Piston FMF
    Hemodialysis Catheter Luer End Cap PEH
    Stopcock, I.V. Set FMG
    Set, Administration, Intravascular FPA
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Adaptor, Catheter GCE
    Oximeter DQA
    Blood Pressure Cuff DXQ
    Catheter, Oximeter, Fiber-Optic DQE
    Catheter, Flow Directed DYG
    Probe, Thermodilution KRB
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    System/Device, Pharmacy Compounding NEP
    Catheter, Intravascular, Diagnostic DQO
    Cap, Device Disinfectant QBP
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Additive Hinge Cap Rio™ Drug Reconstitution Transfer Device Vial Access Spike Universal Vial Access Spike ClearGuard HD Antimicrobial barrier cap SetSource Ext Sets Primary IV Set Universal Spikes Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 NovaCath IV Ext Set Clave Ext Set Ext Set CLAVE Extension Sets Safe Connector Clave Neutral-Displacement Needlefree Connectors ChemoCLAVE Prep System ADAPTOR, CATHETER Cogent Hemodynamic Monitoring System Catheter, oximeter, fiber-optic TEGO Bloof Tubing with Anti Regurgitation Diana Compounding Workflow System Diana Cath Lab Kits SwabTip Male Disinfectant Cap Blood Banking Extension Sets Catheter, Flow Directed PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter CLAVE Vial Access Spike Genie Piggy Lock

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility