capsule, single


Product Overview

capsule, single
SmartPill - 50100100


Device Description

An assembly of devices designed to continuously measure and transmit signals for one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding) from a patient to a receiving location for viewing. It consists of a battery-powered capsule swallowed by the patient, and a patient-worn or clinician-held unit designed to wirelessly receive data from the capsule to either transmit it (i.e., a transceiver) to a computing device or to display it (e.g., a receiver); various solutions/containers may also be included. It is intended to help diagnose gastric pH disorders and/or measure gastrointestinal transit times to evaluate motility disorders.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 40.00
    • 20.00
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 15.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NYV

    Device Name: Gastrointestinal Motility System, Capsule

    Device Class: 2

    Physical State: Small ingestible capsule transmits motility data to a wireless receiver worn by the subject. Data from the receiver is dowloaded into a personal computer (PC) and analyzed with custom software.

    Definition: Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Ingestible telemetric capsule that transmits GI motility data to a wireless receiver worn by the patient.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Device is swallowed, and passes through the GI tract

    Regulation Number: 876.1725

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 04260167482712

    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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