BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

    Reg #: 1314492 · FEI: 1314492 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Baxter Healthcare Corporation
    Registration Number
    1314492
    FEI Number
    1314492
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    711 PARK AVE.
    City
    MEDINA
    State
    NY
    ZIP
    14103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133801

    Owner / Operator

    Firm Name
    BAXTER HEALTHCARE CORPORATION
    Operator Number
    1417572
    Address
    One Baxter Parkway
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Maha Nolasco

    Products

    Device Name Product Code
    Infusion Safety Management Software PHC
    Pump, Infusion FRN

    Proprietary Names

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

    Establishment Types

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