Devices & Diagnostics > Device

DigiDop 301, non-display w recharger, 5MHZ VASCULAR


by NEWMAN MEDICAL LLC
Product Overview

DigiDop 301, non
DigiDop - DD-301-D5


Device Description

An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 75.00
    • 30.00
  • Handling Environment Temperature - Degrees Celsius
    • 40.00
    • 10.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 5.00
  • 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: JAF

    Device Name: Monitor, Ultrasonic, Nonfetal

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: RA

    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: 892.1540

    Third Party Flag: Y

    Medical Specialty: RA


    Device Identifiers

    Device Id: 00852785008104

    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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