BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Peritoneal Dialisys Safe-Lock (4Lead) ECO Drain Set

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3004111573
    FEI Number
    3004111573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1302 Avenue T
    City
    Grand Prairie
    State
    TX
    ZIP
    75050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K811986

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    System, Peritoneal, Automatic Delivery FKX

    Proprietary Names

    Peritoneal Dialisys Safe-Lock (4Lead) ECO Drain Set Peritoneal Dialysis Liberty Drain Set (Compatible with Fresenius Liberty Cycler Sets) Peritoneal Dialysis Safe-Lock (3 Lead) ECO Drain Set ECO ® Peritoneal Dialysis 4 LEAD Prefilled Set with Snap Disconnnect ( For use with Delflex PD Solution Bags and Frese Cyclaear Drain Set eith 4,7 Liter Bags (Compatible with Safe-Lock Connectors) Peritoneal Dialysis Safe-Lock ECO Drain Set Liberty® Safe-Lock® 4 LEAD ECO PREFILLED W/SNAP DISCONNECT

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)