Montesol

Basic Information

• Brand Name: Montesol
• Primary DI: 00744229440758
• Version / Model: 044F6008
• Company Name: PARI RESPIRATORY EQUIPMENT, INC.
• Labeler DUNS: 804736098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-05
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d499c9b0-c1c5-431f-8ae7-e731c67dd8d8

Device Description

Nasal Wash, Montesol

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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
41599	Nasal irrigation applicator	A dispensing device (e.g., a horn-shaped cup or holder, an irrigation bottle, or a device shaped like a tea pot with a bulbous tipped spout) used to apply a liquid treatment, usually a saline solution, directly to the nasal cavity via the nares, typically to clear and clean the mucous membrane and the nasal channels. Typically made of plastic or as a crockery vessel, the device may include a lid and separate base. It may be known as a nose horn because of its design or a Neti pot and is intended for home-use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00744229100522	GS1	carton	12	In Commercial Distribution
Primary	00744229440758	GS1