BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERRAD VELOCITY Biological Indicator (BI) 60 Count

    Reg #: 2084725 · FEI: 3003662624 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    ADVANCED STERILIZATION PRODUCTS
    Registration Number
    2084725
    FEI Number
    3003662624
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    33 TECHNOLOGY DRIVE
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234084

    Owner / Operator

    Firm Name
    Advanced Sterilization Products
    Operator Number
    9068155
    Address
    33 Technology Drive, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Brent Lewis

    Products

    Device Name Product Code
    Indicator, Physical/Chemical Sterilization Process JOJ
    Indicator, Biological Sterilization Process FRC

    Proprietary Names

    STERRAD VELOCITY Biological Indicator (BI) 60 Count STERRAD VELOCITY Biological Indicator (BI) 30 Count STERRAD SEALSURE Chemical Indicator (CI) Tape ULTRA GI Process Challenge Device (PCD) Vial STERRAD Chemical Indicator (CI) Strip STERRAD VELOCITY Reader ULTRA GI Cycle Validation Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device