BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    North American Health & Wellness

    DI: 04719872488507 · Model: JB8150 · HEALTH & LIFE CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    North American Health & Wellness
    Primary DI
    04719872488507
    Version / Model
    JB8150
    Company Name
    HEALTH & LIFE CO., LTD.
    Labeler DUNS
    657836743
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-19
    Public Version
    3
    Public Version Date
    2021-06-08
    Public Version Status
    Update
    Public Device Record Key
    accb1cc2-e324-4686-b927-36a258c37cc7

    Device Description

    Atomizer

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

    GMDN Terms

    Code Name
    10226 Atomizer, non-ventilatory

    Identifiers

    Type ID
    Package 24719872488501
    Primary 04719872488507
    Package 14719872488504

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    5 – 40 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -25 – 70 Degrees Celsius