ROSI xT Tubing set for use with Exchangeable tips, Pouch

Basic Information

• Brand Name: ROSI xT Tubing set for use with Exchangeable tips, Pouch
• Primary DI: 10817122020529
• Version / Model: 106450
• Catalog Number: 106450
• Company Name: VASCULAR TECHNOLOGY, INCORPORATED
• Labeler DUNS: 161989343
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2023-10-10
• Public Version: 1
• Public Version Date: 2023-10-18
• Public Version Status: New
• Public Device Record Key: d2ea6f8a-fc7e-4a77-b339-a537da8d18cc

Device Description

Part Number 106450, ROSI tubing set, Exchangeable tip. Each

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 Unsafe
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47625	Surgical irrigation/aspiration tubing set	A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00817122020522	GS1
Primary	10817122020529	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141323	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry