BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00840682118064 · Model: 2023807-002 · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    00840682118064
    Version / Model
    2023807-002
    Company Name
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Labeler DUNS
    784985108
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-08
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    b05f4ece-0910-44da-a9ed-4a5759b8486a

    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
    47487 Electrical-only medical device connection cable, reusable

    Identifiers

    Type ID
    Primary 00840682118064

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K071073 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 60 Degrees Celsius