BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BPCO Ointment

    DI: 00371351014603 · Model: 1 · Brookfield Pharmaceuticals, Llc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BPCO Ointment
    Primary DI
    00371351014603
    Version / Model
    1
    Company Name
    Brookfield Pharmaceuticals, Llc
    Labeler DUNS
    080592685
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-15
    Public Version
    1
    Public Version Date
    2023-11-23
    Public Version Status
    New
    Public Device Record Key
    dd1fad18-ac42-480c-b01f-9fdc42107736

    Device Description

    Class I (general controls), 510(k) exempt medical device with a product code of NAD. Per the Code of Federal Regulations, it is regulated under 21 CFR 878.4020 as an occlusive wound dressing.

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NAD Dressing, Wound, Occlusive

    GMDN Terms

    Code Name
    62069 Skin semi-occlusive dressing, non-antimicrobial

    Identifiers

    Type ID
    Primary 00371351014603