BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SpO2 Sensor

    DI: 00848530105341 · Model: RES7203 · SUNSET HEALTHCARE SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SpO2 Sensor
    Primary DI
    00848530105341
    Version / Model
    RES7203
    Company Name
    SUNSET HEALTHCARE SOLUTIONS, INC.
    Labeler DUNS
    141668116
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-03
    Public Version
    1
    Public Version Date
    2025-06-11
    Public Version Status
    New
    Public Device Record Key
    b008bd39-e2ae-4fd3-9089-d4fe9c375987

    Device Description

    Sunset SPO2 Sensor - Infant (3-20kg) - 1.5ft cord

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    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
    DQA Oximeter

    GMDN Terms

    Code Name
    37808 Pulse oximeter probe, reusable

    Identifiers

    Type ID
    Package 10848530105348
    Primary 00848530105341
    Package 20848530105345

    Customer Contacts

    Phone
    8775786738
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K070371 000