BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Silicone mask

    DI: 04719872103929 · Model: PN-0503-22A · ENTER MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Silicone mask
    Primary DI
    04719872103929
    Version / Model
    PN-0503-22A
    Company Name
    ENTER MEDICAL CORPORATION
    Labeler DUNS
    658833116
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-19
    Public Version
    2
    Public Version Date
    2023-09-28
    Public Version Status
    Update
    Public Device Record Key
    4a43b496-e414-4b1e-a284-f176932fef92

    Device Description

    Silicone mask provide a method to transfer breathing oxygen gas from a storage tank to lungs

    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
    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
    BYG Mask, Oxygen

    GMDN Terms

    Code Name
    36066 Cardiopulmonary resuscitation mask, reusable

    Identifiers

    Type ID
    Primary 04719872103929