PleurX

Basic Information

• Brand Name: PleurX
• Primary DI: 10885403193026
• Version / Model: 50-7262
• Catalog Number: 50-7262
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-12
• Public Version: 4
• Public Version Date: 2023-08-01
• Public Version Status: Update
• Public Device Record Key: 874e2f6e-c18e-4c01-8fe0-2a0de65e647b

Device Description

PleurX Supplemental Insertion Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNG	Peritoneal, drainage catheter for refractory ascites, long-term indwelling	Gastroenterology, Urology	876.5630	2
DWM	APPARATUS, SUCTION, PATIENT CARE	Cardiovascular	870.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62391	Non-vascular catheter introduction set	A collection of sterile, 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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403193024	GS1	Case	5	In Commercial Distribution
Primary	10885403193026	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]