BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lark Technologies

    DI: 00860008199102 · Model: TMB-2092-G · Lark Technologies, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lark Technologies
    Primary DI
    00860008199102
    Version / Model
    TMB-2092-G
    Company Name
    Lark Technologies, Inc.
    Labeler DUNS
    078312999
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-01
    Public Version
    1
    Public Version Date
    2022-04-11
    Public Version Status
    New
    Public Device Record Key
    b5674ba0-9cc5-4b29-bcd9-dd30ba8e4278

    Device Description

    Digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumfrence range from 22 cm to 45 cm (8 3/4" - 17 1/2"). The device is for indoor use only.

    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

    Identifiers

    Type ID
    Primary 00860008199102
    Package 00860008199119