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    FDA UDI In Commercial Distribution 🇺🇸 United States

    AILE fingertip pulse oximeter

    DI: 06972480913061 · Model: W011 · Jiangxi Aicare Medical Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AILE fingertip pulse oximeter
    Primary DI
    06972480913061
    Version / Model
    W011
    Company Name
    Jiangxi Aicare Medical Technology Co., Ltd.
    Labeler DUNS
    554530454
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-01
    Public Version
    1
    Public Version Date
    2023-04-10
    Public Version Status
    New
    Public Device Record Key
    a5920470-5c17-4e39-ab6e-1ae9d013b6ff

    Device Description

    The fingertip pulse oximeter is intended to measure the pulse oxygen saturation of arterial hemoglobin and pulse rate. This device is not a medical device and is not intended to diagnose and/or treat any medical condition or disease. This device is for Sports and Aviation use only and not for medical use.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    OCH Oximeter, Infrared, Sporting, Aviation

    GMDN Terms

    Code Name
    45607 Pulse oximeter

    Identifiers

    Type ID
    Primary 06972480913061