BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SafetyNeb

    DI: 00817494020694 · Model: AM-NEB-FP · GROMAN INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SafetyNeb
    Primary DI
    00817494020694
    Version / Model
    AM-NEB-FP
    Company Name
    GROMAN INC.
    Labeler DUNS
    020124663
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-01
    Public Version
    1
    Public Version Date
    2023-03-09
    Public Version Status
    New
    Public Device Record Key
    fc9ef63f-bf71-4321-b44a-d4624082e31d
    Distribution End Date
    2123-03-01

    Device Description

    One Kit of SafetyNeb Mask with FacePlate and Nebulizer Tubing

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Safe
    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
    BYF Mask, Oxygen, Low Concentration, Venturi

    GMDN Terms

    Code Name
    35142 Aerosol face mask, rebreathing, single-use

    Identifiers

    Type ID
    Package 10817494020691
    Primary 00817494020694
    Package 20817494020698
    Package 30817494020695