BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MABIS

    DI: 00767056403659 · Model: 40-365-000 · D-M-S HOLDINGS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MABIS
    Primary DI
    00767056403659
    Version / Model
    40-365-000
    Catalog Number
    40-365-000
    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
    2023-05-17
    Public Version Status
    Update
    Public Device Record Key
    ccad74ec-d16d-4d08-a795-626372b3c7b4
    Distribution End Date
    2023-05-16

    Device Description

    NEBPAK BOY ULTRASONIC NEBUILIZER

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CAF Nebulizer (Direct Patient Interface)

    GMDN Terms

    Code Name
    12716 Benchtop nebulizer, heated

    Identifiers

    Type ID
    Package 10767056403656
    Package 30767056403650
    Primary 00767056403659

    Premarket Submissions

    Submission Number Supplement Number
    K002831 000