ULPA Filter


Product Overview

ULPA Filter
OptiMumm - E3625


Device Description

A screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange).


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 75.00
    • 0.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 149.00
    • -29.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FYD

    Device Name: Apparatus, Exhaust, Surgical

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HO

    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: 878.5070

    Third Party Flag: Y

    Medical Specialty: SU


    Device Identifiers

    Device Id: 10884524001081

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 20884524001088

    Package Quantity: 3

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 20884524001088

    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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