BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sheridan Uncuffed Endotracheal Tube

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    147
    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
    K822082

    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
    Tube, Tracheal (W/Wo Connector) BTR

    Proprietary Names

    Sheridan Uncuffed Endotracheal Tube Sheridan Close Fitting Endotracheal Tube SHERIDAN PED-SOFT UNCUFFED¿ Endotracheal Tubes SHERIDAN PREFORMED Endotracheal Tube Sheridan LTS Endotracheal Tube Sheridan HVT Endotracheal Tube SHERIDAN EZ-ENDO Endotracheal Tube ET TUBE PREFORMED CUFFED ORAL 6 ET TUBECF7 ET TUBE UNCUFFED 2 ET TUBE PREFORMED CUFFED ORAL 7.5 ET TUBE UNCUFFED 5.5 ET TUBE PREFORMED UNCUFFED ORAL5.5 ET TUBE PREFORMED CUFFED ORAL 4 ET TUBE UNCUFFED 7 ET TUBEUNCUFFED MAGPED-SOFT4 ET TUBE PREFORMED CUFFED ORAL 9 ET TUBE UNCUFFED 2.5 ET TUBE UNCUFFED PED-SOFT 2.5 ET TUBE PREFORMED CUFFED ORAL 5.5 ET TUBE UNCUFFED MAG 2 ET TUBEUNCUFFEDPED-SOFT6.5 ET TUBE HVT EZ-ENDO 6.5 ET TUBE PREFORMED UNCUFFED NASAL 3.5 ET TUBE PREFORMED UNCUFFED NASAL 7 ET TUBE UNCUFFED MAG 2.5 ET TUBE UNCUFFED EZ-ENDO 3 ET TUBE PREFORMED UNCUFFED NASAL 5.5 ET TUBEUNCUFFED MAGPED-SOFT6 ET TUBECF5.5 ET TUBE HVT 8 ET TUBEHVT7.5NOVA PLUS ET TUBE HVT EZ-ENDO 7.5 ET TUBE PREFORMED CUFFED NASAL 7.5 ET TUBE HVT 6 ET TUBEUNCUFFED MAGPED-SOFT5 ET TUBE PREFORMED UNCUFFED NASAL 5 ET TUBE UNCUFFED MAG 6 ET TUBE HVT 6.5 ET TUBE CF MAG 4 ET TUBE UNCUFFED EZ-ENDO 4.5 ET TUBE UNCUFFED EZ-ENDO 3.5 ET TUBE PREFORMED CUFFED ORAL 5 ET TUBE HVT EZ-ENDO 6 ET TUBEUNCUFFED MAGPED-SOFT3.5 ET TUBE CF MAG 7.5 ET TUBE PREFORMED CUFFED NASAL 7 ET TUBE PREFORMED UNCUFFED ORAL 7 ET TUBE HVT EZ-ENDO 8 ET TUBEUNCUFFED MAGPED-SOFT5.5 ET TUBECF5 ET TUBE HVT EZ-ENDO 9 ET TUBE PREFORMED UNCUFFED ORAL 6 ET TUBE PREFORMED UNCUFFED ORAL 6.5 ET TUBEUNCUFFED MAGPED-SOFT7 ET TUBE HVT EZ-ENDO 7 ET TUBE PREFORMED UNCUFFED ORAL 5 ET TUBEUNCUFFEDPED-SOFT5.5 ET TUBE CF MAG 5 ET TUBE UNCUFFED MAG 4 ET TUBE PREFORMED UNCUFFED NASAL 6 ET TUBE UNCUFFED 6 ET TUBE UNCUFFED EZ-ENDO 2.5 ET TUBE HVT 7.5 ET TUBE PREFORMED UNCUFFED ORAL 3 ET TUBE UNCUFFED 4 ET TUBE PREFORMED CUFFED NASAL 8 ET TUBE PREFORMED UNCUFFED NASAL 6.5 ET TUBE UNCUFFED 3.5 ET TUBE HVT 7 ET TUBELTS6 ET TUBE UNCUFFED MAG 3 ET TUBE CF MAG 8 ET TUBE HVT EZ-ENDO 8.5 ET TUBECF7NOVA PLUS ET TUBEUNCUFFED MAGPED-SOFT2 ET TUBE UNCUFFED MAG 4.5 ET TUBE CF MAG 7 ET TUBEUNCUFFED MAGPED-SOFT6.5 ET TUBE UNCUFFED MAG 7 ET TUBE UNCUFFED 4.5 ET TUBE CF MAG 9.5 ET TUBECF3.5 ET TUBEUNCUFFEDPED-SOFT4 ET TUBE PREFORMED UNCUFFED NASAL 4.5 ET TUBE PREFORMED CUFFED ORAL 7 ET TUBE UNCUFFED MAG 3.5 ET TUBE UNCUFFED PED-SOFT 2 ET TUBEHVT8.5NOVA PLUS ET TUBEUNCUFFED MAGPED-SOFT4.5 ET TUBE CF MAG 6 ET TUBEUNCUFFEDPED-SOFT7 ET TUBECF6.5 ET TUBE UNCUFFED EZ-ENDO 5.5 ET TUBE PREFORMED UNCUFFED ORAL 4 ET TUBECF3 ET TUBE UNCUFFED 5 ET TUBEHVT7NOVA PLUS ET TUBEUNCUFFEDPED-SOFT4.5 ET TUBECF6 ET TUBECF4 ET TUBEUNCUFFEDPED-SOFT5 ET TUBE HVT EZ-ENDO 5.5 ET TUBE PREFORMED CUFFED ORAL 8 ET TUBE UNCUFFED MAG 5.5 ET TUBE HVT EZ-ENDO 5 ET TUBELTS5 ET TUBE HVT 8.5 ET TUBE CF MAG 10 ET TUBECF9 ET TUBE CF MAG 8.5 ET TUBECF9.5 ET TUBE PREFORMED CUFFED NASAL 6 ET TUBE CF MAG 9 ET TUBE HVT 10 ET TUBEHVT8NOVA PLUS ET TUBECF4.5 ET TUBE UNCUFFED PED-SOFT 3 ET TUBE PREFORMED UNCUFFED ORAL 4.5 ET TUBE UNCUFFED 6.5 ET TUBE PREFORMED CUFFED ORAL 4.5 ET TUBE PREFORMED UNCUFFED ORAL3.5 ET TUBEUNCUFFEDPED-SOFT3.5 ET TUBE PREFORMED UNCUFFED NASAL 3 ET TUBECF8.5 ET TUBE UNCUFFED 3 ET TUBE PREFORMED CUFFED NASAL 6.5 ET TUBE UNCUFFED MAG 6.5 ET TUBE UNCUFFED MAG 5 ET TUBE UNCUFFED EZ-ENDO 5 ET TUBE PREFORMED UNCUFFED NASAL 4 ET TUBE PREFORMED CUFFED ORAL 8.5 ET TUBEUNCUFFEDPED-SOFT6 ET TUBECF8 ET TUBE UNCUFFED EZ-ENDO 4 ET TUBECF10 ET TUBE HVT 9 ET TUBECF7.5 ET TUBE HVT 5 ET TUBEUNCUFFED MAGPED-SOFT2.5 ET TUBEUNCUFFED MAGPED-SOFT3 ET TUBE CF MAG 3 ET TUBE HVT 5.5 SHERIDAN PED-SOFT UNCUFFED Endotracheal Tubes ET TUBE PREFORMED CUFFED ORAL 6.5 ET TUBE CF MAG 6.5 ET TUBELTS4

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)