BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Scope Buddy Endoscope Flushing Aid

    Reg #: 2150060 · FEI: 2150060 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Medivators Inc
    Registration Number
    2150060
    FEI Number
    2150060
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14605 28th Avenue North
    City
    MINNEAPOLIS
    State
    MN
    ZIP
    55447
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162128

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    2150060
    Address
    5960 Heisley Rd
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Accessories, Cleaning, For Endoscope FEB

    Proprietary Names

    Scope Buddy Endoscope Flushing Aid Scope Buddy Plus Endoscope Flushing Aid Scope Buddy Plus Tubing

    Establishment Types

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