BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CONFORMat Evolution

    DI: B970CEC5330533120 · Model: CONFORMat 2 System with Clinical Software · Tekscan, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CONFORMat Evolution
    Primary DI
    B970CEC5330533120
    Version / Model
    CONFORMat 2 System with Clinical Software
    Catalog Number
    CEC5330-5331-2
    Company Name
    Tekscan, Inc.
    Labeler DUNS
    178180246
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-03
    Public Version
    2
    Public Version Date
    2020-11-19
    Public Version Status
    Update
    Public Device Record Key
    c363ab69-44a3-47b7-9095-ba17f676af75

    Device Description

    Includes 2 Evolution Handles, CONFORMat Clinical Software CD with 5330, 5331, and 5330_5331 Maps, (1) 5330-5 and (1) 5331-5 Sensors, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, 1 Web-based Training Session (USA Only)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JFC System, Pressure Measurement, Intermittent

    GMDN Terms

    Code Name
    43829 Body-surface pressure mapping system

    Identifiers

    Type ID
    Primary B970CEC5330533120