PleurX Supplemental Insertion Kit

PleurX Supplemental Insertion Kit
PleurX - 50-7262

A collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. 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

Code: DWM

Device Name: Apparatus, Suction, Patient Care

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.5050

Third Party Flag: Y

Medical Specialty: CV

Device Id: 50885403193024

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403193026

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 10885403193026

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