BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    ICU Medical Costa Rica Ltd.

    Reg #: 9615050 · FEI: 3002999813 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    ICU Medical Costa Rica Ltd.
    Registration Number
    9615050
    FEI Number
    3002999813
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 Km Noreste del Centro Comercial Real Cariari, ZONA FRANCA GLOBAL Park
    City
    La Aurora de Heredia
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K042800

    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
    Pump, Infusion, Pca MEA
    Set, Administration, Intravascular FPA
    Pump, Infusion FRN
    Accessories, Pump, Infusion MRZ
    Neuraxial Administration Set - Intrathecal Delivery PYR
    Tube, Aspirating, Flexible, Connecting BYY
    Endoscopic Central Control Unit ODA
    Set, I.V. Fluid Transfer LHI
    Container, I.V. KPE
    Infusion Safety Management Software PHC
    Tubing, Fluid Delivery FPK
    Catheter, Irrigation GBX

    Proprietary Names

    Lifecare PCA Infusion system Sapphire Sets CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Ad Infusion Set Plum DuoTM Infusion System Extension Set THORACENTESIS SET, 30 Inch PLUM A+ Infusion System Plum Solo Precision IV Pump Plum Duo Precision IV Pump Lifecare PCA Infusion System Lifecare 5000 Infusion System Two-Way Transfer Device PLUM XL Infusion System Burette Set Medfusion Sapphire Set Empty Container and Infusion Set PLUM 360 Infusion System Administration Set Administration Sets: Primary Sets, Extension Sets, Burette Sets, Blood Sets Irrigation Set Infusion Pump System with Administration Set Primary Set Blood Set Infusion Blood Set Nutrimix Empty Container Infusion System CADD®-Solis VIP Ambulatory Infusion System Gemstar Infusion Sets Sterile Empty Container

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)