BIOS Diagnostics

GUDID 10057475160514

Nasal Irrigator

Thermor Ltd

Nasal irrigation set, home-use
Primary Device ID10057475160514
NIH Device Record Key0b5b2eed-7c72-4938-ab71-23377e199d57
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOS Diagnostics
Version Model NumberNS160
Company DUNS246883458
Company NameThermor Ltd
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100057475160517 [Primary]
GS110057475160514 [Package]
Contains: 00057475160517
Package: Case [12 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 Date2024-06-25
Device Publish Date2024-06-17

On-Brand Devices [BIOS Diagnostics]

20057475508498Cardiology Stethoscope
80057475507493Deluxe Dual Head Stethoscope
80057475506496Sprague Rappaport Stethoscope
10057475220492Glass Thermometer
20057475363059Cooling Gel Patches (4 Pack)
20057475244105Blood Pressure Monitor/Automatic AFIB
10057475160514Nasal Irrigator

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.