BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Pulse oximeter

    DI: D040200121301 · Model: 20012130 · WHIP-MIX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pulse oximeter
    Primary DI
    D040200121301
    Version / Model
    20012130
    Company Name
    WHIP-MIX CORPORATION
    Labeler DUNS
    006385173
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-01
    Public Version
    5
    Public Version Date
    2022-09-30
    Public Version Status
    Update
    Public Device Record Key
    b4c7ee1c-2931-4bbd-952c-ffa90fad5bd1
    Distribution End Date
    2022-09-29

    Device Description

    The GEM is an easy to use Pulse Oximeter that utilizes cloud technology for convenient and prompt readings. The GEM is designed to assess the functioning of the airway using SPO2 and variations in heart rate to measure how well the airway is functioning. The Oximeter measures the blood oxygen level and heart rate then transmits the data to the Galaxy Tablet for storage and processing

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DQA Oximeter

    GMDN Terms

    Code Name
    37808 Pulse oximeter probe, reusable

    Identifiers

    Type ID
    Primary D040200121301