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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Getinge Assure S.M.A.R.T. Green Sterilizer Mechanical Air Removal Test

    DI: 00814434020745 · Model: 61301606625 · STERITEC PRODUCT MFG. CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Getinge Assure S.M.A.R.T. Green Sterilizer Mechanical Air Removal Test
    Primary DI
    00814434020745
    Version / Model
    61301606625
    Catalog Number
    61301606625
    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
    0516659b-9901-45ab-9832-ebedd11ed4ea

    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 10814434020742
    Primary 00814434020745

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 32 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    30 – 70 Percent (%) Relative Humidity