PleurX Supplemental Insertion Kit
PleurX - 50-7262
Device Description
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.
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: 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 IdentifiersDevice 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
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