BEUDAMED
    FDA Registration Active 🇺🇸 United States

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

    Reg #: 1649518 · FEI: 3001236277 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1649518
    FEI Number
    3001236277
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3125 Wichita Court
    City
    Fort Worth
    State
    TX
    ZIP
    76140
    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)