BEUDAMED
    FDA Registration Active 🇺🇸 United States

    All-Silicone Foley Catheter

    Reg #: 1030583 · FEI: 1030583 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    C.R. BARD, INC.
    Registration Number
    1030583
    FEI Number
    1030583
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    428 POWERHOUSE RD.
    City
    MONCKS CORNER
    State
    SC
    ZIP
    29461
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040504

    Owner / Operator

    Firm Name
    C. R. Bard, Inc.
    Operator Number
    2212754
    Address
    1 Becton Drive
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    All-Silicone Foley Catheter Lubri-Sil I.C. Foley Catheter (offered in strips and trays) Bardex Silicone Foley Catheter (offered in strips and trays) Lubri-Sil Foley Catheter (offered in strips and trays)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)