RELIEVA VORTEX 2

Basic Information

• Brand Name: RELIEVA VORTEX 2
• Primary DI: 10705031205871
• Version / Model: RV02
• Catalog Number: RV02
• Company Name: ACCLARENT, INC.
• Labeler DUNS: 361092450
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-01
• Public Version: 4
• Public Version Date: 2020-01-22
• Public Version Status: Update
• Public Device Record Key: c55e7b4a-8705-4b8a-a9eb-1889ab955862

Device Description

RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER

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: Yes
• 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
KAR	IRRIGATOR, SINUS	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48141	Paranasal sinus irrigation catheter	A sterile flexible tube designed to introduce fluid (e.g., saline solution) into the sinus cavities to provide irrigation for the flushing and removal of mucus, pus, and blood from the site of intervention. It typically consists of a single-lumen tube with end and/or side holes at the distal end; the proximal end is typically connected to a syringe or irrigation fluid pumping system via a Luer-lock. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705031205878	GS1	BOX	5	In Commercial Distribution
Primary	10705031205871	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place