Peritoneal Dialysis

Basic Information

• Brand Name: Peritoneal Dialysis
• Primary DI: 00884450462751
• Version / Model: 00884450462751
• Catalog Number: CSS-242
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-22
• Public Version: 2
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 694dfe0e-c096-467c-83e0-c010b22ec8d9

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• 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
FKX	System, peritoneal, automatic delivery	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13837	Peritoneal catheter stylet	A thin wire/rod intended to be inserted within the lumen of a peritoneal catheter (e.g., peritoneal dialysis catheter, peritoneal drainage catheter, peritoneal lavage catheter, abdominal fluid shunt system peritoneal catheter) to stiffen/maintain the shape of the catheter to assist introduction; it may also be intended to assist insertion of a bladder catheter used for drainage of fluid from the peritoneal cavity to the bladder. It is intended to be removed once the catheter is in place. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884450462758	GS1		1	In Commercial Distribution
Primary	00884450462751	GS1