DD-II 330 Non-Display Doppler, 2MHz waterproof obstetrical probe

Product Overview

DigiDop - DD-330-D2W

Device Description

A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.

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: 00852785008258

    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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