Catheter Access Kit, For use with the PleurX or PeritX Catheter Systems
N/A - 50-7280A
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 50885403502406
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403502408
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 10885403502408
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