Ritus

Basic Information

• Brand Name: Ritus
• Primary DI: 10884521811287
• Version / Model: 8813791001
• Company Name: Mozarc Medical US LLC
• Labeler DUNS: 118997146
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-20
• Public Version: 1
• Public Version Date: 2026-04-28
• Public Version Status: New
• Public Device Record Key: d3073115-d039-4e8c-b56c-0872de219643

Device Description

Chronic Catheter Accessory,Injection Sealing Cap

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: 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
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16858	Catheter injection port	A device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. Some types may be designed as a Y-connector with an additional inlet (e.g., with a female Luer connection point) to facilitate sequential injection and infusion of fluids (e.g., medication followed by saline). It may be additionally intended for use as a heparin/saline lock by keeping the flush solution in the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521811287	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K844193	000