ASEPT PERITONEAL DRAINAGE SYSTEM


Product Overview

ASEPT PERITONEAL DRAINAGE SYSTEM
ASEPT - 622284


Device Description

A sterile flexible tube designed for percutaneous insertion into the peritoneal space typically to drain ascites and abdominal abscesses. It may include disposable devices dedicated to catheter introduction, however it does not include any fluid collection bags/containers. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • KEEP DRY
  • Special Storage Condition, Specify
    • Keep away from sunlight
  • Special Storage Condition, Specify
    • Store at room temp

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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: 04046964317330

    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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