BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vital Signs

    DI: 50607514500009 · Model: 2 · OXEHEALTH LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vital Signs
    Primary DI
    50607514500009
    Version / Model
    2
    Company Name
    OXEHEALTH LIMITED
    Labeler DUNS
    218519521
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-21
    Public Version
    1
    Public Version Date
    2025-01-29
    Public Version Status
    New
    Public Device Record Key
    614c0f06-d4b3-4757-bf0c-97d205bc42ea

    Device Description

    Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And Respiratory Rate

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

    GMDN Terms

    Code Name
    63535 Near-infrared camera vital sign measurement software

    Identifiers

    Type ID
    Primary 50607514500009