BEUDAMED
    FDA Registration Active 🇺🇸 United States

    86201 5.5 Oral RAE Tracheal Tube Cuffed Murphy

    Reg #: 1721686 · FEI: 1721686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1721686
    FEI Number
    1721686
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2400 Airport Rd
    City
    Santa Teresa
    State
    NM
    ZIP
    88008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K941246

    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

    86201 5.5 Oral RAE Tracheal Tube Cuffed Murphy 76270 Oral RAE TaperGuard Cuffed 7mm 86207 8.5 Oral RAE Tracheal Tube Cuffed Murphy 96370 Nasal RAE TaperGuard Cuffed 7mm 86203 6.5 Oral RAE Tracheal Tube Cuffed Murphy 76280 Oral RAE TaperGuard Cuffed 8mm 76285 Oral RAE TaperGuard Cuffed 8.5mm 86206 8 Oral RAE Tracheal Tube Cuffed Murphy 96375 Nasal RAE TaperGuard Cuffed 7.5mm 86209 4 Oral RAE Tracheal Tube Cuffed Murphy 86202 6 Oral RAE Tracheal Tube Cuffed Murphy 76255 Oral RAE TaperGuard Cuffed 5.5mm 96365 Nasal RAE TaperGuard Cuffed 6.5mm 86208 9 Oral RAE Tracheal Tube Cuffed Murphy 86199 4.5 Oral RAE Tracheal Tube Cuffed Murphy 76275 Oral RAE TaperGuard Cuffed 7.5mm 96360 Nasal RAE TaperGuard Cuffed 6mm 96380 Nasal RAE TaperGuard Cuffed 8mm 86200 5 Oral RAE Tracheal Tube Cuffed Murphy 86286 4.5 Nasal RAE Tracheal Tube Uncuffed 76251 Oral RAE TaperGuard Cuffed 5mm 76260 Oral RAE TaperGuard Cuffed 6mm 86204 7 Oral RAE Tracheal Tube Cuffed Murphy 76290 Oral RAE TaperGuard Cuffed 9mm 76265 Oral RAE TaperGuard Cuffed 6.5mm 86205 7.5 Oral RAE Tracheal Tube Cuffed Murphy 86288 5.5 Nasal RAE Tracheal Tube Uncuffed 86284 3.5 Nasal RAE Tracheal Tube Uncuffed 86291 7 Nasal RAE Tracheal Tube Uncuffed M6DCT Shiley Modified Disposable Cannula Low Pressure Cuffed Tracheostomy Tube 86289 6 Nasal RAE Tracheal Tube Uncuffed

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)