Vital Signs® Disposable Esophageal Stethoscope with Temperature Probe, Non-Sterile, 24FR


Product Overview

Vital Signs® Disposable Esophageal Stethoscope with Temperature Probe, Non
Vital Signs - 1012EU


Device Description

An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 35.00
    • 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: FLL

    Device Name: Continuous Measurement Thermometer

    Device Class: 2

    Physical State: The device may be a patch that is applied on or a probe that is used with a patient. Patches may include adhesive backing to allow the device to adhere to the target location. Probes are used invasively or non-invasively and may be connected wired or wirelessly to a compatible monitor or other device.

    Definition: A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.

    Submission Type ID: 1

    Review Panel: HO

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The device is a contact or non-contact thermometer indicated to measure a person’s temperature. Temperature may be measured continuously, at pre-specified intervals, or remotely at the request of the user. The device output is displayed either on the device or may be transferred to a compatible monitor or device via a wired or wireless connection.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: The device may be used externally on a person’s skin, used invasively including inside the esophagus or rectum, or ingested.

    Regulation Number: 880.2910

    Third Party Flag: Y

    Medical Specialty: HO


    Device Identifiers

    Device Id: 50885403288287

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403288289

    Package Quantity: 50

    Package Discontinue Date: 3/31/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Case


    Device Id: 10885403288289

    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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