BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BD Alaris Systems Manager

    Reg #: 2016493 · FEI: 2016493 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    CareFusion 303, INC.
    Registration Number
    2016493
    FEI Number
    2016493
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    10020 Pacific Mesa Blvd
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211218

    Owner / Operator

    Firm Name
    CAREFUSION 303, INC.
    Operator Number
    9068764
    Address
    10020 Pacific Mesa Blvd., --
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US

    Products

    Device Name Product Code
    Infusion Safety Management Software PHC
    Pump, Infusion FRN
    Pump, Infusion, Pca MEA
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK

    Proprietary Names

    BD Alaris Systems Manager BD Alaris System Maintenance Infusion Adapter BD Alaris Guardrails Editor BD Alaris Syringe Module BD Alaris Pump Module BD Alaris PC Unit BD Alaris System with Guardrails Suite MX v12.1.2 Alaris Auto-ID Module BD Alaris EtCO2 Module Calculation Services Alaris PCA Module

    Establishment Types

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