Product Overview

Linkview - 100011-032

Device Description

An electrically-powered device assembly designed for use in the home to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., blood pressure, blood glucose, pulse rate, temperature, haemoglobin oxygen saturation (SpO2), and possibly calculate mean arterial pressure (MAP)]. It typically includes a main analysis unit with a visual display, and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, blood glucose meter) or external devices (e.g., USB cable). It may be used in a healthcare facility and in the home.

Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 131.00
    • -4.00

  • Device Sizes

    No Data Available

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: DRG

    Device Name: Transmitters And Receivers, Physiological Signal, Radiofrequency

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.2910

    Third Party Flag: Y

    Medical Specialty: CV

    Device Identifiers

    Device Id: 00763000001964

    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

    Educational Resources