BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HEPRO.US MM1000 Blood Glucose Monitoring System Kit

    DI: 00854427007148 · Model: KIT - Glucose Monitoring System · HEPRO.US INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HEPRO.US MM1000 Blood Glucose Monitoring System Kit
    Primary DI
    00854427007148
    Version / Model
    KIT - Glucose Monitoring System
    Company Name
    HEPRO.US INC.
    Labeler DUNS
    080061451
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    9c3aa190-e42c-4670-82d6-4317a4198256

    Device Description

    Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lancets, 1 logbook, 1 user manual

    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
    CGA Glucose Oxidase, Glucose
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    61913 Glucose/haematocrit monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 00854427007148