Sensica Tube Band Positioning Strip - ICU


Product Overview

Sensica Tube Band Positioning Strip
Sensica UO System - STBM1025


Device Description

An assembly of devices intended to automatically and continuously monitor and display a patient's urine output (urine flow/volume). The system typically consists of a battery-powered, portable monitor with controls, digital display, alarms, and memory; an electronic (e.g., optical) urine output sensor; and a disposable urine collection container. The system is typically used in situations where fluid and renal management are critical to patient treatment and care [e.g., during diuresis monitoring in the intensive care unit (ICU)].


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 30.00
  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • 5.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: EXS

    Device Name: Urinometer, Electrical

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: GU

    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: 876.1800

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 10801741215732

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00801741215735

    Package Quantity: 25

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: BX


    Device Id: 00801741215735

    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


    Device Id: 20801741215739

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10801741215732

    Package Quantity: 8

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA


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