BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 06923980105487 · Model: AD0051 · GaleMed Xiamen Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    N/A
    Primary DI
    06923980105487
    Version / Model
    AD0051
    Company Name
    GaleMed Xiamen Co., Ltd.
    Labeler DUNS
    527333326
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-22
    Public Version
    1
    Public Version Date
    2026-01-30
    Public Version Status
    New
    Public Device Record Key
    175b96f4-ad4f-4568-a110-b161ed18cdd7

    Device Description

    Neb.Easy AM-1 Mask, Child w/Tube

    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
    No
    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
    CAF Nebulizer (Direct Patient Interface)

    GMDN Terms

    Code Name
    31309 Nebulizing system delivery set, single-use

    Identifiers

    Type ID
    Package 46923980105485
    Primary 06923980105487