BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TruSignal SpO2

    DI: 00840682103275 · Model: TS-PAW · GE Healthcare Finland Oy
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TruSignal SpO2
    Primary DI
    00840682103275
    Version / Model
    TS-PAW
    Company Name
    GE Healthcare Finland Oy
    Labeler DUNS
    401966697
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-27
    Public Version
    4
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    eb81dd08-06cb-43a2-ae5f-56872c31418b

    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
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DQA Oximeter
    DPZ Oximeter, ear

    GMDN Terms

    Code Name
    31658 Pulse oximeter probe, single-use

    Identifiers

    Type ID
    Package 00840682116725
    Primary 00840682103275
    Package 00840682116688

    Customer Contacts

    Phone
    +1(800)558-5120
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K040831 000
    K093881 000
    K132696 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 60 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    5 – 95 Percent (%) Relative Humidity