AccessGUDID - DEVICE: Acoustic Rhinometer (05060485270027)

GUDID

Device Identifier (DI) Information

Brand Name: Acoustic Rhinometer
Version or Model: A1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: GM INSTRUMENTS LIMITED

Primary DI Number: 05060485270027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 771009610 *Terms of Use

Device Description: A line powered (AC- powered), or powered via a connected computer, electronic device designed to allow the internal profile of the nose to be recorded in order to quantify the degree of obstruction/congestion in the nasal cavities and provide monitoring of the consequences of therapy or surgery. A nosepiece conducts a sound pulse produced by an integrated sound generator to the patient's nose and the sound reflections from the nose are detected where changes in cross-sectional areas are encountered. It is a computer-based device with dedicated software for processing the output and return signals to produce plots of cross-sectional areas as a function of distance in the nose.

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?
57974	Acoustic rhinometer	A line-powered (AC-powered), or powered via a connected computer, electronic device designed to allow the internal profile of the nose to be recorded in order to quantify the degree of obstruction/congestion in the nasal cavities and provide monitoring of the consequences of therapy or surgery. A nosepiece conducts a sound pulse produced by an integrated sound generator to the patient?s nose and the sound reflections from the nose are detected where changes in cross-sectional areas are encountered. It is a computer-based device with dedicated software for processing the outgoing and return signals to produce plots of cross-sectional areas as a function of distance in the nose.	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 [?]
Premarket Submission Number Not Available/Not Released

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b90e4cc6-fa08-4abb-a66d-bf0d17170885
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 19, 2016