PleurX Catheter Access Kit

PleurX Catheter Access Kit
PleurX - 50-7280

A collection of devices intended to be used in conjunction with a pleural drainage catheter (not included) to manually infuse pharmaceutical agents (e.g., sclerosing agent) [not included] into the pleural cavity, and for catheter flushing/maintenance; it may in addition be intended for manual aspiration of fluids. It includes a catheter/syringe needless valve connector with a syringe and typically additional supportive devices (e.g., clamps, wipes/dressings); 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: 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

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: 50885403185692

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403185694

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 10885403185694

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