AccessGUDID - DEVICE: ECCOVISION Pharyngometer (00860719000339)

GUDID

Device Identifier (DI) Information

Brand Name: ECCOVISION Pharyngometer
Version or Model: 21000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Legacy 21000
Company Name: SLEEP GROUP SOLUTIONS, LLC

Primary DI Number: 00860719000339
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039583619 *Terms of Use

Device Description: The Legacy Pharyngometer is used for an objective assessment of the oral and pharyngeal spaces

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):	Yes
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 [?]
K011329	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd6a513e-ae46-4873-a12d-0c3ba19d5f0b
Public Version Date: March 12, 2019
Public Version Number: 4
DI Record Publish Date: September 19, 2016