Easy Air Mini Sinus Irrigation System

Basic Information

• Brand Name: Easy Air Mini Sinus Irrigation System
• Primary DI: 00850632007508
• Version / Model: NI-50
• Catalog Number: 7508
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Labeler DUNS: 783518983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-20
• Public Version: 1
• Public Version Date: 2019-09-30
• Public Version Status: New
• Public Device Record Key: 5438926f-ec09-4447-9ec4-54d579b4b11b

Device Description

The Nasal irrigator is used to clean mucus from nasal passage making medication more effective. It can also help to clean allergens, irritants, bacteria and viruses from the nose, reducing the frequency of infection as well as decreasing swelling in the nose and increasing air flow.

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: Yes
• 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
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	874.5550	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	10850632007505	GS1	Outer Carton	32	In Commercial Distribution
Primary	00850632007508	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	100	Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 158 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity