SFTWR 8870AAU01 N'VISION AAU/01


Product Overview

SFTWR 8870AAU01 N'VISION AAU/01
N'VISION® - 8870AAU01


Device Description

An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 135.00
    • -30.00
  • Storage Environment Temperature - Degrees Celsius
    • 57.00
    • -34.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LKK

    Device Name: Pump, Infusion, Implanted, Programmable

    Device Class: 3

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 2

    Review Panel: HO

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00643169640863

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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