BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CONFORMat VersaTek Datalogger

    DI: B970CVD20 · Model: CONFORMat 2 VersaTek Datalogger System · Tekscan, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CONFORMat VersaTek Datalogger
    Primary DI
    B970CVD20
    Version / Model
    CONFORMat 2 VersaTek Datalogger System
    Catalog Number
    CVD2
    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
    1f5f14e3-c17e-40c7-962f-6d6ea372fe1e

    Device Description

    Includes 2 VersaTek Cuffs, 1 VersaTek Datalogger Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File, PDF of System Manual and Datalogger software features, (2) 5330E Sensors, Formatted Memory Stick, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, Trigger Switch, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 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 B970CVD20