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    FDA Registration Active 🇺🇸 United States

    US_Endoscopy4223 (PL) - AquaShield System CO2 FUJIFILM

    Reg #: 2246552 · FEI: 2246552 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    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
    K191559

    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
    Pump, Air, Non-Manual, For Endoscope FEQ

    Proprietary Names

    US_Endoscopy4223 (PL) - AquaShield System CO2 FUJIFILM US_Endoscopy4223 (PL) - AquaShield System- CO2 PENTAX US_Endoscopy4223(PL) - AquaShield System- PENTAX US_Endoscopy4223 (PL) - AquaShield System CO2

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)