BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sunbeam

    DI: 00694501169856 · Model: TMB-1583-S · Star Elite Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sunbeam
    Primary DI
    00694501169856
    Version / Model
    TMB-1583-S
    Company Name
    Star Elite Inc
    Labeler DUNS
    201197410
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-01
    Public Version
    1
    Public Version Date
    2021-07-09
    Public Version Status
    New
    Public Device Record Key
    20c096c4-eefc-4e22-8921-57a55a149c84

    Device Description

    Upper arm blood pressure monitor intended for use in adults to measure heartbeat rate and blood pressure.

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    Package 30694501169857
    Primary 00694501169856