DENVER™ ASCITES SHUNT PERCUTANEOUS ACCESS KIT SINGLE VALVE


Product Overview

DENVER™ ASCITES SHUNT PERCUTANEOUS ACCESS KIT SINGLE VALVE
Denver - 42-2055


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

  • Number of Valves: 1
  • Catheter Gauge: 11.5 French
    • Number of Valves: 1
    • Catheter Gauge: 11.5 French


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KPM

    Device Name: Shunt, Peritoneal

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: Y

    Target Area: N/A

    Regulation Number: 876.5955

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 50885403076006

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403076008

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: Case


    Device Id: 10885403076008

    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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