FDA.reportPublic FDA data

Rhinomanometer

Primary DI
05060485270034
Brand
Rhinomanometer
Company
GM INSTRUMENTS LIMITED
Model
NR6
Catalog number
N/A
Device description
An electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow within a patient's nasal passages, e.g., for the calculation of the nasal patency during ear/nose/throat (ENT) assessment/treatment. It is used to quantify the amount of nasal obstruction/congestion and is a computer-based device with dedicated software for data calculation, presentation (display), and storage purposes. This device will be powered via a connected computer and include or interface with a printer for hard copies of the graphical data presentation.
Published
2017-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BXQRhinoanemometer (Measurement Of Nasal Decongestion)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXQRhinoanemometer (Measurement Of Nasal Decongestion)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902120000MERCURY RHINOMANOMETERLife-Tech Intl., Inc.1990-08-06BXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060485270034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060485270034050604852700345060485270034

GMDN Terms#

Term, Definition table
TermDefinition
Computerized rhinomanometerAn electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow within a patient's nasal passages, e.g., for the calculation of the nasal patency during ear/nose/throat (ENT) assessment/treatment. It is used to quantify the amount of nasal obstruction/congestion and is a computer-based device with dedicated software for data calculation, presentation (display), and storage purposes. This device will typically be line-powered (AC-powered) or powered via a connected computer and include or interface with a printer for hard copies of the graphical data presentation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
771009610
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060485270027Acoustic RhinometerA1N/A2016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009626805VISIONAIRPACIFICMD BIOTECH, LLCBXQ2023-02-07
00860719000360ECCOVISION Pharyngometer and Rhinometer SLEEP GROUP SOLUTIONS, LLCBXQ2019-03-11
00860719000322Eccovision Rhinometer and PharyngometerSLEEP GROUP SOLUTIONS, LLCBXQ2016-09-19
00860719000339ECCOVISION PharyngometerSLEEP GROUP SOLUTIONS, LLCBXQ2016-09-19
00860719000308ECCOVISION RhinometerSLEEP GROUP SOLUTIONS, LLCBXQ2016-09-01
05060485270027Acoustic RhinometerGM INSTRUMENTS LIMITEDBXQ2016-08-19