BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Moldex Airwave Surgical N95 Respirator

    DI: 00092311415000 · Model: 4150 · MOLDEX-METRIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    8

    Basic Information

    Brand Name
    Moldex Airwave Surgical N95 Respirator
    Primary DI
    00092311415000
    Version / Model
    4150
    Company Name
    MOLDEX-METRIC, INC.
    Labeler DUNS
    066237736
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    8
    Record Status
    Published
    Publish Date
    2022-02-25
    Public Version
    2
    Public Version Date
    2023-09-13
    Public Version Status
    Update
    Public Device Record Key
    3da5115a-b3de-4352-a6cb-670659dfda2d

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    MSH Respirator, Surgical

    GMDN Terms

    Code Name
    57794 Surgical/medical respirator, non-antimicrobial, single-use

    Identifiers

    Type ID
    Package 50092311415005
    Primary 00092311415000
    Unit of Use 10092311415007