BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Getinge Assure AccuFast Biological Test Pack with 5 Controls

    DI: 00814434020295 · Model: 61301606638 · 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 AccuFast Biological Test Pack with 5 Controls
    Primary DI
    00814434020295
    Version / Model
    61301606638
    Catalog Number
    61301606638
    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
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    61dc49f5-ce7c-4280-ba37-3ea4c4e1d6d2

    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
    FRC Indicator, Biological Sterilization Process

    GMDN Terms

    Code Name
    13732 Biological sterilization indicator

    Identifiers

    Type ID
    Package 10814434020292
    Primary 00814434020295

    Storage Conditions

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