BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Embrace Control Solution Hi

    DI: 00894030002697 · Model: APX02AB0511 · OMNIS HEALTH
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Embrace Control Solution Hi
    Primary DI
    00894030002697
    Version / Model
    APX02AB0511
    Company Name
    OMNIS HEALTH
    Labeler DUNS
    023891520
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-23
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    98f1cb9e-d7ea-4f30-8a6d-5ba8a439c033

    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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    LFR Glucose Dehydrogenase, Glucose
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    30854 Home-use/point-of-care blood glucose monitoring system IVD

    Identifiers

    Type ID
    Primary 00894030002697