Rhinomanometer N/A

GUDID 05060485270034

An electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow within a patient's nas

GM INSTRUMENTS LIMITED

Computerized rhinomanometer
Primary Device ID05060485270034
NIH Device Record Keycd453142-31d4-4e57-b1b6-d8d99503994a
Commercial Distribution StatusIn Commercial Distribution
Brand NameRhinomanometer
Version Model NumberNR6
Catalog NumberN/A
Company DUNS771009610
Company NameGM INSTRUMENTS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060485270034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BXQRhinoanemometer (Measurement Of Nasal Decongestion)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-17

Devices Manufactured by GM INSTRUMENTS LIMITED

05060485270034 - Rhinomanometer2018-07-06An electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow within a patient's nas
05060485270034 - Rhinomanometer2018-07-06 An electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow
05060485270027 - Acoustic Rhinometer2018-03-29 A line powered (AC- powered), or powered via a connected computer, electronic device designed to allow the internal profile of t

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