BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Chummie

    DI: 00854950002030 · Model: TC300P · Theos Medical Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Chummie
    Primary DI
    00854950002030
    Version / Model
    TC300P
    Company Name
    Theos Medical Systems, Inc.
    Labeler DUNS
    808427392
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-01-04
    Public Version
    1
    Public Version Date
    2024-01-12
    Public Version Status
    New
    Public Device Record Key
    87059c9f-6480-432b-be8d-00154383ae62

    Device Description

    A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability, and may be used in the home or a healthcare facility.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    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
    KPN Alarm, Conditioned Response Enuresis

    GMDN Terms

    Code Name
    11588 Incontinence sensor/alarm

    Identifiers

    Type ID
    Primary 00854950002030