BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FORA

    DI: 00816042014024 · Model: VSM100 Pro · FORA CARE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FORA
    Primary DI
    00816042014024
    Version / Model
    VSM100 Pro
    Company Name
    FORA CARE INC.
    Labeler DUNS
    004340807
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-18
    Public Version
    2
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    a155345e-3cb7-42e7-86d5-ef3c0bccbff2

    Device Description

    Vital Signs Monitor (Bluetooth)

    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
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

    GMDN Terms

    Code Name
    33586 General-purpose multi-parameter bedside monitor

    Identifiers

    Type ID
    Primary 00816042014024

    Premarket Submissions

    Submission Number Supplement Number
    K090395 000
    K101259 000
    K120042 000