3MHz waterproof obstetrical probe (probe only)

Product Overview

3MHz waterproof obstetrical probe (probe only)
DigiDop - D3W

Device Description

A hand-operated component of a foetal Doppler system intended to be placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.

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: LXE

    Device Name: Doppler, Fetal, Ultrasound

    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: 884.2660

    Third Party Flag: Y

    Medical Specialty: OB

    Device Identifiers

    Device Id: 00852785008562

    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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