BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CareFusion 303, INC.

    Reg #: 2016493 · FEI: 2016493 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    49
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    CareFusion 303, INC.
    Registration Number
    2016493
    FEI Number
    2016493
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    10020 Pacific Mesa Blvd
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043299

    Owner / Operator

    Firm Name
    CareFusion 303, INC.
    Operator Number
    9068764
    Address
    3750 Torrey View Ct, --
    City
    San Diego
    State
    CA
    Postal Code
    92130
    Country
    US

    Products

    Device Name Product Code
    Pump, Infusion, Pca MEA
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Cabinet, Table And Tray, Anesthesia BRY
    Oximeter DQA
    Pump, Infusion FRN
    Infusion Safety Management Software PHC

    Proprietary Names

    Alaris PCA Alaris/Medley EtCO2 Module BD Pyxis Anesthesia Station ES BD Pyxis MedStation 4000 BD Pyxis MedBank Tower BD Pyxis Medflex 2000 BD Pyxis MedStation ES Tower BD Pyxis MedBank Tower Auxiliary BD Pyxis Medflex 1000 BD Pyxis MedStation ES BD Pyxis Med Auxiliary (AUX) BD Pyxis Med Auxiliary (AUX) Tower BD Pyxis MedBank Mini BD Pyxis Anesthesia Station 4000 BD Pyxis MedBank Mini Auxiliary BD Pyxis ES Refrigerator BD Pyxis Pro MedStation Dispensing System BD Pyxis MedStation 4000 Integrated Main BD Pyxis MedBank CUBIE Replenishment Station BD Pyxis CUBIE System BD Pyxis Enterprise Server Alaris/Medley SpO2 Module Alaris System with MMS Alaris/Medley Syringe Module Alaris System with Guardrails Suite MX Alaris/Medley Bar Code Module BD Alaris™ PCU Module, Model 8015 BD Alaris™ Infusion Adapter Software Alaris™ Guardrails™ Editor Software BD Alaris™ System Manager 9601, Software BD Alaris™ Syringe Module, Model 8110 BD Alaris™ Pump Module, Model 8100 BD Alaris™ ETC02 Module, Model 8300 Alaris™ System Maintenance Software Alaris™ PCA Module, Model 8120 BD Alaris™ Calculation Services, Software BD Alaris™ System with Guardrails Suite Software Alaris™ Auto-ID Module BD Alaris™ Auto-ID Module BD Alaris™ PC Unit BD Alaris™ System Maintenance Software BD Alaris™ PCU Module, Model 8015, Software BD Alaris™ ETCO2 Module, Model 8300 BD Alaris™ Syringe Module, Model 8110, Software Alaris™ PCA Module, Model 8120, Software BD Alaris™ System with Guardrails Suite MX BD Alaris™ ETC02 Module, Model 8300, Software BD Alaris™ Pump Module, Model 8100, Software Alaris PC Unit

    Establishment Types

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