BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medrad® PRES™ Pressure-Rated Extension Set

    Reg #: 2520313 · FEI: 2520313 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Bayer Medical Care Inc.
    Registration Number
    2520313
    FEI Number
    2520313
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Bayer Drive
    City
    INDIANOLA
    State
    PA
    ZIP
    15051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083723

    Owner / Operator

    Firm Name
    Bayer Medical Care Inc.
    Operator Number
    2520313
    Address
    1 Bayer Drive
    City
    Indianola
    State
    PA
    Postal Code
    15051
    Country
    US
    Correspondent
    Troy A Jack

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA

    Proprietary Names

    Medrad® PRES™ Pressure-Rated Extension Set

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198