AccessGUDID - DEVICE: Rhinomanometer (05060485270034)

GUDID

Device Identifier (DI) Information

Brand Name: Rhinomanometer
Version or Model: NR6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: GM INSTRUMENTS LIMITED

Primary DI Number: 05060485270034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 771009610 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17228	Computerized rhinomanometer	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 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXQ	Rhinoanemometer (Measurement Of Nasal Decongestion)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K902120	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cd453142-31d4-4e57-b1b6-d8d99503994a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 17, 2017