BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Face Mask

    DI: 10851253007912 · Model: S-10478-S1 · ULINE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Face Mask
    Primary DI
    10851253007912
    Version / Model
    S-10478-S1
    Company Name
    ULINE, INC.
    Labeler DUNS
    039612668
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2020-03-09
    Public Version
    4
    Public Version Date
    2022-12-05
    Public Version Status
    Update
    Public Device Record Key
    c496168d-c71c-4c1c-a696-bde236e8d007

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FXX Mask, Surgical

    GMDN Terms

    Code Name
    35177 Surgical/medical face mask, single-use

    Identifiers

    Type ID
    Package 30851253007916
    Primary 10851253007912
    Unit of Use 00851253007915