Product Overview

NA - TOCO TRANSDUCER WATERTIGHT LOOP


Device Description

An electrically-powered device designed for continuous monitoring of foetal heart activity and maternal uterine contractions during the prenatal (commonly perinatal) period; it may monitor additional maternal parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse oximetry (SpO2)]. Also known as a cardiotocograph, uterine contractions are acquired using a tocodynamometer (pressure transducer) strapped onto the mother's abdomen, while foetal heart rate is typically measured with a dedicated ultrasound transducer. The results may be displayed via print-out or electronically; telemetry features may also be included.


Environmental Conditions

  • Storage Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 70.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 5.00
  • Storage Environment Temperature - Degrees Celsius
    • 55.00
    • -10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: HFM

    Device Name: Monitor, Uterine Contraction, External (For Use In Clinic)

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: OB

    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: 884.2720

    Third Party Flag: Y

    Medical Specialty: OB


    Code: HEL

    Device Name: Monitor, Heart Rate, Fetal, Ultrasonic

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: OB

    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: 00840682104227

    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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