BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Central Hub Speaker

    DI: 00850064210194 · Model: 900-00004 · Sibel Health Inc.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Central Hub Speaker
    Primary DI
    00850064210194
    Version / Model
    900-00004
    Company Name
    Sibel Health Inc.
    Labeler DUNS
    093772547
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-27
    Public Version
    1
    Public Version Date
    2025-04-04
    Public Version Status
    New
    Public Device Record Key
    2e888036-2a36-4db9-8df4-a5abad823cc9

    Device Description

    Central Hub Speaker

    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
    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
    MSX System, Network And Communication, Physiological Monitors
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
    KMI Monitor, Bed Patient
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

    GMDN Terms

    Code Name
    65831 Wearable multiple vital physiological parameter monitor

    Identifiers

    Type ID
    Primary 00850064210194