LARGE ADULT CUFF CUFF SET


Product Overview

LARGE ADULT CUFF CUFF SET
DOPPLEX - ACC-VAS-011


Device Description

An automated, battery-powered, portable electronic device designed to calculate the ankle brachial pressure index (ABPI), used in the diagnosis of peripheral vascular disease (PVD), from simultaneous oscillometric measurement of the ankle and brachial blood pressure indices. It typically consists of a control/analysis/display unit with cuffs placed around an arm and one or both ankles; it uses integrated transducers to measure cuff pressure oscillations which represent the fluctuations of pressure in the underlying blood vessels. The device is typically operated by a healthcare professional.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - millibar
    • 1060.00
    • 860.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 10.00
  • Handling Environment Temperature - Degrees Celsius
    • 35.00
    • 10.00
  • Storage Environment Atmospheric Pressure - millibar
    • 1060.00
    • 860.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 50.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JOM

    Device Name: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

    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: 870.2780

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 05051968030375

    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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