BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    ICU MEDICAL DE MEXICO, S. de R.L. de C.V.

    Reg #: 9617594 · FEI: 3003807466 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    55
    Establishment Types
    3
    Classifications
    24

    Registration Details

    Registration Name
    ICU MEDICAL DE MEXICO, S. de R.L. de C.V.
    Registration Number
    9617594
    FEI Number
    3003807466
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Avenida Cuarzo No. 250, Colonia Rancho Santa Clara, Maneadero
    City
    ENSENADA, Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K970855

    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

    US Agent

    Business Name
    ICU MEDICAL, INC.
    Contact Name
    Michelle Doherty
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    ZIP
    92673
    Country
    US
    Email
    [email protected]
    Phone
    949 3706562

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Transducer, Blood-Pressure, Extravascular DRS
    Stopcock, I.V. Set FMG
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Syringe, Piston FMF
    Set, I.V. Fluid Transfer LHI
    Catheter, Intravascular, Diagnostic DQO
    Tubes, Gastrointestinal (And Accessories) KNT
    Catheter, Oximeter, Fiber-Optic DQE
    Catheter, Continuous Flush KRA
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Cap, Device Disinfectant QBP
    Adaptor, Catheter GCE
    Needle, Hypodermic, Single Lumen FMI
    Pump, Infusion FRN
    Infusion Safety Management Software PHC
    Container, I.V. KPE
    Probe, Thermodilution KRB
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Catheter, Straight EZD
    Accessories, Catheter, G-U KNY
    Accessories, Catheter KGZ
    Tubing, Fluid Delivery FPK

    Proprietary Names

    CLAVE Connector Smartvalve IV Ext Set Clave Ext Set Ext Set CLAVE Extension Sets Clave Neutral-Displacement Needlefree Connectors Expressions MR Transpac IV SetSource Ext Sets Primary IV Set Diana ChemoLock Transfer Set Vial Access Spike Rio™ Drug Reconstitution Transfer Device Safe Connector Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 Cath Lab Kits Disposable Transducer Monitoring Kits Lopez Valve PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter Safeset Dye Management System Pull Tab Squeeze Flush High Pressure Sets Antimicrobial CLAVE SwabTip Male Disinfectant Cap ADAPTOR, CATHETER Spinning Spiros Stopcock Extension Sets Piggy Lock CLAVE Vial Access Spike Cardiac Catheterization Kit PLUM 360 Infusion System Additive Hinge Cap Transpac IT Universal Vial Access Spike Thermoset Genie ChemoCLAVE Prep System SwabCap Bloof Tubing with Anti Regurgitation CLAVE Stopcock Universal Spikes Spiros High Pressure Tubing NovaCath ChemoLock ChemoPort Graduated Adapter With CLAVE Neutron Blood Banking Extension Sets Extension Set Syringe Adaptor Single Lead Dispensing Set TEGO

    Establishment Types

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