PeritX Peritoneal Catheter and Starter Kit, For Peritoneal Placement Only and For Patient Home Use

PeritX Peritoneal Catheter and Starter Kit, For Peritoneal Placement Only and For Patient Home Use
PeritX - 50-9900C

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.

No Data Available

No Data Available

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: 10885403501838

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