BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CHOLESTEROL HDL 2G CALIBRATOR

    DI: 03661540215100 · Model: HDLL-0041 · ELITECH CLINICAL SYSTEMS SAS
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CHOLESTEROL HDL 2G CALIBRATOR
    Primary DI
    03661540215100
    Version / Model
    HDLL-0041
    Company Name
    ELITECH CLINICAL SYSTEMS SAS
    Labeler DUNS
    267732378
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2022-03-08
    Public Version Status
    Update
    Public Device Record Key
    d99917a6-4291-481e-ba3c-ac04fe6ea828

    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

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 03661540215100