BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ENLIGHT PATIENT REFERENCE CABLE

    DI: 07898966433290 · Model: ACE-00034 · Timpel S/A
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ENLIGHT PATIENT REFERENCE CABLE
    Primary DI
    07898966433290
    Version / Model
    ACE-00034
    Company Name
    Timpel S/A
    Labeler DUNS
    897939320
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-10
    Public Version
    2
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    631bec36-9096-4b05-aca0-94cc67d624c2

    Device Description

    The reference cable is connected to a common ECG-like electrode applied to the patient to acquire reference signal of electric impedance data. The accessory has been developed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized.

    Device Characteristics

    Single Use
    Yes
    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
    QEB Ventilatory Electrical Impedance Tomograph

    GMDN Terms

    Code Name
    35750 Analytical non-scalp cutaneous lead

    Identifiers

    Type ID
    Primary 07898966433290

    Premarket Submissions

    Submission Number Supplement Number
    DEN170072 000