BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tempus Pro

    DI: 05060472440211 · Model: 01-2068 · REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tempus Pro
    Primary DI
    05060472440211
    Version / Model
    01-2068
    Company Name
    REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
    Labeler DUNS
    896707940
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    4
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    487913bb-9e8a-4f9e-9cd3-486996c1f814

    Device Description

    Tempus Pro 3-Lead ECG Cable (AAMI) 8ft

    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
    No
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    GMDN Terms

    Code Name
    36872 Multiple vital physiological parameter monitoring system, clinical

    Identifiers

    Type ID
    Primary 05060472440211