PleurX Peritoneal Catheter Kit, For Peritoneal Placement, 15.5 Fr
PleurX - 50-9000B
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
- 25.00
- 20.00
Device Sizes
- Catheter Gauge: 15.5 French
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 IdentifiersDevice Id: 50885403075955
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403075957
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 10885403075957
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