BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MABIS

    DI: 00767056181502 · Model: 18-150-000 · D-M-S HOLDINGS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MABIS
    Primary DI
    00767056181502
    Version / Model
    18-150-000
    Catalog Number
    18-150-000
    Company Name
    D-M-S HOLDINGS, INC.
    Labeler DUNS
    062028220
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2023-05-10
    Public Version Status
    Update
    Public Device Record Key
    f8bf6611-0de1-41c0-b6ba-6cb2083b6d96
    Distribution End Date
    2023-05-09

    Device Description

    PROBE COVERS FOR EAR THERMOMETER (18-100)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FLL Thermometer, Electronic, Clinical

    GMDN Terms

    Code Name
    13116 Electronic thermometer probe cover

    Identifiers

    Type ID
    Package 10767056181509
    Package 20767056181506
    Package 30767056181503
    Primary 00767056181502

    Premarket Submissions

    Submission Number Supplement Number
    K102508 000