BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 00840682103084 · Model: OXIMAX, 1.2M ,2021406-002 · GE Healthcare Finland Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    00840682103084
    Version / Model
    OXIMAX, 1.2M ,2021406-002
    Company Name
    GE Healthcare Finland Oy
    Labeler DUNS
    401966697
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-16
    Public Version
    4
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    3af0492f-fed9-44ad-971a-905224551069

    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
    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
    MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

    GMDN Terms

    Code Name
    37808 Pulse oximeter probe, reusable

    Identifiers

    Type ID
    Primary 00840682103084

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K051367 000

    Storage Conditions

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