BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SteriTec Steam Integrator X 2

    DI: 00814434020196 · Model: CI 143 · STERITEC PRODUCT MFG. CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SteriTec Steam Integrator X 2
    Primary DI
    00814434020196
    Version / Model
    CI 143
    Catalog Number
    CI 143
    Company Name
    STERITEC PRODUCT MFG. CO., INC.
    Labeler DUNS
    622223196
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    789e9c8e-4253-430f-a634-58d1695c9082

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JOJ Indicator, Physical/Chemical Sterilization Process

    GMDN Terms

    Code Name
    35362 Chemical/physical sterilization process indicator

    Identifiers

    Type ID
    Package 20814434020190
    Package 10814434020193
    Primary 00814434020196

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    10 – 70 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    10 – 38 Degrees Celsius