BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HeartsCare C1 Total Cholesterol Test Strip (10pcs/box)

    DI: 00850014861346 · Model: TD-4289 · Hearts Bio, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HeartsCare C1 Total Cholesterol Test Strip (10pcs/box)
    Primary DI
    00850014861346
    Version / Model
    TD-4289
    Company Name
    Hearts Bio, Inc.
    Labeler DUNS
    085509873
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-11
    Public Version
    1
    Public Version Date
    2022-04-19
    Public Version Status
    New
    Public Device Record Key
    ce755c10-5647-4d3d-b1ab-fd1621b1dc5f

    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
    Yes
    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
    CHH Enzymatic Esterase--Oxidase, Cholesterol

    GMDN Terms

    Code Name
    53362 Total cholesterol lipid IVD, reagent

    Identifiers

    Type ID
    Primary 00850014861346