BEUDAMED
    FDA Registration Active 🇺🇸 United States

    4 LEAD NEWTON IQ® SET ( For use with Delflex PD Solution Bags and Fresenius Newton IQ Cycler Compatible with Safe-Lock

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    K904806

    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
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ

    Proprietary Names

    4 LEAD NEWTON IQ® SET ( For use with Delflex PD Solution Bags and Fresenius Newton IQ Cycler Compatible with Safe-Lock Stay¿safe Extension set, 6 in. with Safe-Lock patient connector compatible with stay¿safe peritoneal dialysis connectol SAFE-LOCK DRAIN LINE ECO ® Peritoneal Dialysis 3 LEAD Prefilled Set with Snap Disconnnect ( For use with Delflex PD Solution Bags and Frese Newton IQ® 4 Lead Cycler Set with Stay¿safe 4 Lead Cycler Set with Single patient connector Compatible with stay¿safe Stay¿safe Extension set, 18 in. with Safe-Lock patient connector compatible with stay¿safe peritoneal dialysis connect C.A.P.D. Disposable Freedom Set with Povidone-iodine Gel Safe-Lock Connector and Snap Disconnect Stay¿safe Extension set, 12 in. with Safe-Lock patient connector compatible with stay¿safe peritoneal dialysis connect Stay Safe ® Safe-Lock® CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)