PleurX Vacuum Bottle, With Drainage Line, 1000 mL


Product Overview

PleurX Vacuum Bottle, With Drainage Line, 1000 mL
PleurX - 50-7210


Device Description

A collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Total Volume: 1000 Milliliter
    • Total Volume: 1000 Milliliter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DWM

    Device Name: Apparatus, Suction, Patient Care

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: AN

    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: 870.5050

    Third Party Flag: Y

    Medical Specialty: CV


    Code: PNG

    Device Name: Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

    Device Class: 2

    Physical State: Plastic tubing with a tissue ingrowth cuff and valve or connector.

    Definition: For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Typically attached to positive pressure or gravity feed to assist in drainage of fluid from the peritoneal cavity.

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: Peritoneal Cavity.

    Regulation Number: 876.5630

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 50885403090668

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403090660

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


    Device Id: 10885403090660

    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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