BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    iWay

    DI: 06970005397013 · Model: iway 13 · Shenzhen Witleaf Medical Electronics Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    iWay
    Primary DI
    06970005397013
    Version / Model
    iway 13
    Company Name
    Shenzhen Witleaf Medical Electronics Co., Ltd.
    Labeler DUNS
    403635526
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-03
    Public Version
    1
    Public Version Date
    2024-04-11
    Public Version Status
    New
    Public Device Record Key
    c803bd96-194e-4322-bec6-6910c6fcc675

    Device Description

    Nasopharyngeal airway for oxygenation and capnography

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BTQ Airway, Nasopharyngeal

    GMDN Terms

    Code Name
    42422 Nasopharyngeal airway, single-use

    Identifiers

    Type ID
    Primary 06970005397013