BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Portrait CAU01

    DI: 00840682139250 · Model: CAU01 · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    5
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Portrait CAU01
    Primary DI
    00840682139250
    Version / Model
    CAU01
    Catalog Number
    2102549-001
    Company Name
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Labeler DUNS
    006580799
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-05
    Public Version
    1
    Public Version Date
    2023-10-13
    Public Version Status
    New
    Public Device Record Key
    272e7577-3999-4092-9de2-c11df457a58b

    Device Description

    Portrait Clinical Alarming Unit CAU01

    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
    Yes
    Has Lot/Batch Number
    No
    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
    MWI Monitor, physiological, patient (without arrhythmia detection or alarms)
    DRG TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
    MSX System, network and communication, physiological monitors
    BZO SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

    GMDN Terms

    Code Name
    62911 Physiologic monitoring system alarm

    Identifiers

    Type ID
    Primary 00840682139250

    Premarket Submissions

    Submission Number Supplement Number
    K230626 000