N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10885403502408
• Version / Model: 50-7280A
• Catalog Number: 50-7280A
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-09
• Public Version: 2
• Public Version Date: 2021-03-18
• Public Version Status: Update
• Public Device Record Key: b0d72cda-2e62-4412-94d0-58d4c47505a9

Device Description

Catheter Access Kit, For use with the PleurX or PeritX Catheter Systems

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
DWM	APPARATUS, SUCTION, PATIENT CARE	Cardiovascular	870.5050	2
PNG	Peritoneal, drainage catheter for refractory ascites, long-term indwelling	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64112	Pleural catheter syringe-infusion set	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403502406	GS1	Case	5	In Commercial Distribution
Primary	10885403502408	GS1

Customer Contacts

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