BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HeartsCare C1 Plus Multi-Functional Monitoring System

    DI: 00850014861056 · Model: TD-4289 · Hearts Bio, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HeartsCare C1 Plus Multi-Functional Monitoring System
    Primary DI
    00850014861056
    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
    2025-03-31
    Public Version
    1
    Public Version Date
    2025-04-08
    Public Version Status
    New
    Public Device Record Key
    887fcdf4-4416-4156-a9f7-6153fbd111bd

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NBW System, Test, Blood Glucose, Over The Counter
    CHH Enzymatic Esterase--Oxidase, Cholesterol
    JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

    GMDN Terms

    Code Name
    56675 Multiple clinical chemistry analyser IVD, home-use

    Identifiers

    Type ID
    Primary 00850014861056