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 #: 1649518 · FEI: 3001236277 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    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)