Ritus

Basic Information

• Brand Name: Ritus
• Primary DI: 10884521797185
• Version / Model: 8817791002
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-23
• Public Version: 2
• Public Version Date: 2023-09-20
• Public Version Status: Update
• Public Device Record Key: 8c2502e2-c5db-48a4-b4cf-3da51ae9ec5e

Device Description

Peritoneal Dialysis Catheter Tunneling Device and Plug

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
FJS	Catheter, peritoneal, long-term indwelling	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61354	Peritoneal dialysis catheter introduction set	A collection of sterile devices, which includes at least one invasive device, intended to assist percutaneous placement of a peritoneal dialysis catheter (not included). The kit includes devices intended to assist catheter insertion (e.g., dilators, insertion sheath) and may include additional non-dedicated catheterization support devices (e.g., dressings); it does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521797185	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K213602	000