BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HealthWise Embrace TALK Pre-Pack (3x12)

    DI: 00894030002963 · Model: APX03AB0312HWPR · OMNIS HEALTH, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HealthWise Embrace TALK Pre-Pack (3x12)
    Primary DI
    00894030002963
    Version / Model
    APX03AB0312HWPR
    Company Name
    OMNIS HEALTH, LLC
    Labeler DUNS
    824763358
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-02
    Public Version
    1
    Public Version Date
    2019-12-10
    Public Version Status
    New
    Public Device Record Key
    87b07705-1b93-465a-aeca-223ee0b6ba1a

    Device Description

    3 x Embrace TALK Monitor 12 x Embrace TALK Test Strip 50ct.

    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
    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
    LFR Glucose Dehydrogenase, Glucose
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    62537 Glucose monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 00894030002963

    Premarket Submissions

    Submission Number Supplement Number
    K090043 000