BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Urinary drainage collection kit, for indwelling catheter

    Reg #: 1061124 · FEI: 1000512168 · 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
    1061124
    FEI Number
    1000512168
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10821 Withers Cove Park Dr
    City
    Charlotte
    State
    NC
    ZIP
    28278
    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)