PleurX Peritoneal Catheter and Starter Kit - For Peritoneal Placement Only and For Patient Home Use

PleurX Peritoneal Catheter and Starter Kit
PleurX - 50-9900

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.

• Catheter Gauge: 15.5 French
• Total Volume: 1000 Milliliter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 10885403231537

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

Device Id: 50885403231535

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403231537

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 20885403231534

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403231537

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box