BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Device Respiratory Accessory Kit

    DI: 00709078009167 · Model: 0791 · WESTMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Device Respiratory Accessory Kit
    Primary DI
    00709078009167
    Version / Model
    0791
    Company Name
    WESTMED, INC.
    Labeler DUNS
    092673953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-31
    Public Version
    1
    Public Version Date
    2020-09-08
    Public Version Status
    New
    Public Device Record Key
    d0e7bfab-fcfe-4f89-90ce-2b2a0fe16738

    Device Description

    Respiratory Accessory Kit- Adult & Pediatric Mask

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BYG Mask, Oxygen

    GMDN Terms

    Code Name
    35174 Partial-rebreathing oxygen face mask

    Identifiers

    Type ID
    Package 10709078009164
    Primary 00709078009167