BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HDL Ultra Calibrator Kit

    DI: 00628063400577 · Model: 6272-3 · SEKISUI DIAGNOSTICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    HDL Ultra Calibrator Kit
    Primary DI
    00628063400577
    Version / Model
    6272-3
    Catalog Number
    6272-3
    Company Name
    SEKISUI DIAGNOSTICS, LLC
    Labeler DUNS
    966812344
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    3
    Public Version Date
    2022-03-08
    Public Version Status
    Update
    Public Device Record Key
    2ea7159f-8544-4bc4-b261-a44eee965348

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    JIS CALIBRATOR, PRIMARY

    GMDN Terms

    Code Name
    44696 High density lipoprotein (HDL) cholesterol IVD, calibrator

    Identifiers

    Type ID
    Primary 00628063400577
    Unit of Use 10628063400574