BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Urinary drainage collection kit, for indwelling catheter

    Reg #: 2029015 · FEI: 1000160458 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    43
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029015
    FEI Number
    1000160458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    687 S Wanamaker Ave
    City
    Ontario
    State
    CA
    ZIP
    91761
    Country
    US

    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
    Urinary Drainage Collection Kit, For Indwelling Catheter FCN

    Proprietary Names

    Urinary drainage collection kit, for indwelling catheter MEDICAL DEVICES INTERNATIONAL (MDI)- Drainage Bags P400 Premium Urine Meter: P4P14SD P400 Premium Urine Meter: P4P18ULP Catch Kit: 5205 P400 Premium Urine Meter: P4P18XSD P400 Premium Urine Meter: P4P18XTSD P400 Premium Urine Meter: P4P16TSD France prc Advantage: FPP16UL ULTRAMER Foley Tray Latex Cath: 6166LL France prc Advantage: FPP18UL P400 Premium Urine Meter: P4PAD P400 Premium Urine Meter: P4P18CSDK P400 Premium Urine Meter: P4P18SD P400 Premium Urine Meter: P4P18TS P400 Premium Urine Meter: P4P18TSD P400 Premium Urine Meter: P4P18XCSDK P400 Premium Urine Meter: P4P18ULD P400 Premium Urine Meter: P4P18CSD P400 Premium Urine Meter: P4P16CSDK P400 Premium Urine Meter: P4P14XSD ULTRAMER Foley Tray Latex Cath: 6165LL ULTRAMER Foley Tray Latex Cath: 6164LL P400 Premium Urine Meter: P4P16SD France prc Advantage: FPP20UL Add-A-Foley: 6176LL P400 Premium Urine Meter: P4P16XSD Add-A-Foley: 6175 P400 Premium Urine Meter: P4P16ts P400 Premium Urine Meter: P4P18XTS Catch Kit: 5204 P400 Premium Urine Meter: P4P16XTS Add-A-Foley: 6256 France prc Advantage: FPP14UL P400 Premium Urine Meter: P4P14ULD P400 Premium Urine Meter: P4P16ULD P400 Premium Urine Meter: P4P16ULP P400 Premium Urine Meter: P4P14TSD Add-A-Foley: 6175MF P400 Premium Urine Meter: P4P16XTSD P400 Premium Urine Meter: P4P16XCSDK France prc Advantage: FPP12UL P400 Premium Urine Meter: P4P16CSD

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)