BEUDAMED
    FDA Registration Active 🇺🇸 United States

    5PDC Shiley Cuffed Pediatric Tracheostomy Tube

    Reg #: 1721686 · FEI: 1721686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    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
    K955680

    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 Tracheostomy And Tube Cuff JOH

    Proprietary Names

    5PDC Shiley Cuffed Pediatric Tracheostomy Tube 5.5PLC Shiley Cuffed Long Pediatric Tracheostomy Tube 4.5PDC Shiley Cuffed Pediatric Tracheostomy Tube 6PLC Shiley Cuffed Long Pediatric Tracheostomy Tube 6.5PLC Shiley Cuffed Long Pediatric Tracheostomy Tube 5.5PDC Shiley Cuffed Pediatric Tracheostomy Tube 4PDC Shiley Cuffed Pediatric Tracheostomy Tube M5.5PLC Shiley Modified Cuffed Long Pediatric Tracheostomy Tube M5.5PDC Shiley Modified Cuffed Pediatric Tracheostomy Tube M6PLC Shiley Modified Cuffed Long Pediatric Tracheostomy Tube 5PLC Shiley Cuffed Long Pediatric Tracheostomy Tube M6.5PLC Shiley Modified Cuffed Long Pediatric Tracheostomy Tube M5PDC Shiley Modified Cuffed Pediatric Tracheostomy Tube M4PDC Shiley Modified Cuffed Pediatric Tracheostomy Tube M4.5PDC Shiley Modified Cuffed Pediatric Tracheostomy Tube M5PLC Shiley Modified Cuffed Long Pediatric Tracheostomy Tube

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)