BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Patient Protection Mask

    DI: 00709078008603 · Model: PPM-Kit · WESTMED, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Patient Protection Mask
    Primary DI
    00709078008603
    Version / Model
    PPM-Kit
    Company Name
    WESTMED, INC.
    Labeler DUNS
    092673953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-15
    Public Version
    1
    Public Version Date
    2020-05-25
    Public Version Status
    New
    Public Device Record Key
    1b4553b7-7e17-4bf2-88d7-4f0c593d1a56

    Device Description

    Adult Non-Vented Mask, Exchangeable Bacterial Viral Filter

    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
    Yes
    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
    CAH Filter, Bacterial, Breathing-Circuit
    BYG Mask, Oxygen

    GMDN Terms

    Code Name
    35172 Aerosol face mask, non-rebreathing

    Identifiers

    Type ID
    Package 10709078008600
    Primary 00709078008603

    Premarket Submissions

    Submission Number Supplement Number
    K922492 000