BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HUMAN DESIGN MEDICAL

    DI: 00859477004161 · Model: US · BREAS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HUMAN DESIGN MEDICAL
    Primary DI
    00859477004161
    Version / Model
    US
    Catalog Number
    HD60-1017
    Company Name
    BREAS MEDICAL, INC.
    Labeler DUNS
    079296736
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-14
    Public Version
    4
    Public Version Date
    2019-04-19
    Public Version Status
    Update
    Public Device Record Key
    8c3d61cd-9fcd-4fb4-841d-c0c3ef75bf3f

    Device Description

    Ventilator, Non Continuous Respirator with Battery Source

    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
    BZD Ventilator, Non-Continuous (Respirator)

    GMDN Terms

    Code Name
    60711 Home CPAP unit

    Identifiers

    Type ID
    Primary 00859477004161

    Customer Contacts

    Phone
    855-436-8729
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K140929 000