Naväge

Basic Information

• Brand Name: Naväge
• Primary DI: 00850027492698
• Version / Model: SNM-1
• Company Name: Rhinosystems, Inc.
• Labeler DUNS: 008016231
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-15
• Public Version: 1
• Public Version Date: 2024-11-25
• Public Version Status: New
• Public Device Record Key: 4787631c-4821-4a75-a5ae-f96819a47ac8

Device Description

Saline Nasal Mist

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCJ	Applicator, Ent	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56700	Nasal irrigation saline solution	A water-based, salt solution (e.g., isotonic or hypertonic mineral-rich purified sea water) intended to penetrate, clear, clean, and sometimes hydrate the nasal passages and sinus cavity. The solution is typically self-administered (e.g., via a squeeze bottle, glass bottle with a mechanical spray pump, dropper or aerosol) for preventive or symptomatic nasal care. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850027492698	GS1

Customer Contacts

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