BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    All-in-One Health Monitor

    DI: 06941900603523 · Model: PC-303 · Shenzhen Creative Industry Co., Ltd.
    View on AccessGUDID
    Product Codes
    6
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    All-in-One Health Monitor
    Primary DI
    06941900603523
    Version / Model
    PC-303
    Company Name
    Shenzhen Creative Industry Co., Ltd.
    Labeler DUNS
    547908801
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-29
    Public Version
    3
    Public Version Date
    2020-09-22
    Public Version Status
    Update
    Public Device Record Key
    8768ba04-6b83-4e12-aae6-46042f949895

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DSH Recorder, Magnetic Tape, Medical
    NBW System, Test, Blood Glucose, Over The Counter
    FLL Thermometer, Electronic, Clinical
    DQA Oximeter
    DXN System, Measurement, Blood-Pressure, Non-Invasive
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

    GMDN Terms

    Code Name
    57960 Multiple physiological parameter spot-check system, clinical

    Identifiers

    Type ID
    Primary 06941900603523

    Premarket Submissions

    Submission Number Supplement Number
    K170047 000