BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Navilyst5285 (PL) - Xcela

    Reg #: 2246552 · FEI: 2246552 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    2246552
    FEI Number
    2246552
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3459 SOUTH CLINTON AVE.
    City
    S Plainfield
    State
    NJ
    ZIP
    07080
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163452

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    9072619
    Address
    5960 Heisley Road, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Midline Catheter PND

    Proprietary Names

    Navilyst5285 (PL) - Xcela Navilyst5285 (PL) -BioFlo PICC Navilyst5285 (PL) - BioFlo Midline

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)