FDA.reportPublic FDA data

Easy Air Mini Sinus Irrigation System

Primary DI
00850632007508
Brand
Easy Air Mini Sinus Irrigation System
Company
HOME AIDE DIAGNOSTICS, INC.
Model
NI-50
Catalog number
7508
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.
Published
2019-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMAIrrigator, Powered Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMAIrrigator, Powered NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850632007505PackageGS132In Commercial Distribution
00850632007508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085063200750510850632007505
00850632007508008506320075088506320075080850632007508

GMDN Terms#

Term, Definition table
TermDefinition
Nasal irrigation applicatorA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit158 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-915-0116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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00850027494654"Easy Comfort Syringes 31G 5/16"" 0.3CC"46542024-10-08
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00850027494975Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count49752024-10-08
00850027494982Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count49822024-10-08
00850027494999Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count49992024-10-08
00891237001034Comfort Heal Heating PadJY610110342018-02-14
00850027494517Smart Neb Pediatric NebulizerSNebPN2023-11-03
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00850632007553Pure Air Mini NebulizerMCN-S600A2020-03-24
00891237001607Easy Air Compressor NebulizerMCN-S600MC16072016-05-01
00850058864082Easy Comfort 3L Sharps Container {3.17 Quarts}SC3L2024-06-14
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Primary DI, Brand, Company table
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