Product Overview

Aspirator - 2510

Device Description

A portable assembly of devices, which includes an orally-introduced handpiece/tip, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). In addition to the handpiece/tip, it includes a manually-powered (hand or foot-operated) suction pump, a collection container, and typically microbial/hydrophobic filters. The system is not intended for surgical use.

Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • -40.00

  • Device Sizes

    No Data Available

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: BTA

    Device Name: Pump, Portable, Aspiration (Manual Or Powered)

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: SU

    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: 878.4780

    Third Party Flag: Y

    Medical Specialty: SU

    Device Identifiers

    Device Id: 05099169251007

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 15099169251004

    Package Quantity: 1

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A

    Device Id: 15099169251004

    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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