BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HemoSphere

    Reg #: 3032916632 · FEI: 3032916632 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    BECTON, DICKINSON AND COMPANY
    Registration Number
    3032916632
    FEI Number
    3032916632
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17200 Laguna Canyon Rd
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231248

    Owner / Operator

    Firm Name
    Becton, Dickinson and Company
    Operator Number
    10093301
    Address
    17200 Laguna Canyon Road
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Karen M O'Leary

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Plethysmograph, Impedance DSB
    Transducer, Blood-Pressure, Extravascular DRS
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Catheter, Flow Directed DYG
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Oximeter, Fiber-Optic DQE
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    HemoSphere Swan-Ganz Jr catheter ClearSight Jr finger cuff FloTrac Jr sensor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility