Easy Air Mini Sinus Irrigation System 7508

GUDID 10850632007505

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.

HOME AIDE DIAGNOSTICS, INC.

Nasal irrigation applicator
Primary Device ID10850632007505
NIH Device Record Key5438926f-ec09-4447-9ec4-54d579b4b11b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy Air Mini Sinus Irrigation System
Version Model NumberNI-50
Catalog Number7508
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-915-0116
Emailinfo@homeaide.us

Device Dimensions

Total Volume100 Milliliter

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100850632007508 [Primary]
GS110850632007505 [Package]
Contains: 00850632007508
Package: Outer Carton [32 Units]
In Commercial Distribution

FDA Product Code

KMAIrrigator, Powered Nasal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-30
Device Publish Date2019-09-20

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