AccessGUDID - DEVICE: Instrumentation Difra (B51617481)

GUDID

Device Identifier (DI) Information

Brand Name: Instrumentation Difra
Version or Model: CoolStar 230V 3.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17481
Company Name: Instrumentation Difra SA

Primary DI Number: B51617481
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 370173410 *Terms of Use

Device Description: The air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produces involuntary eye movements. The handle is equipped with an otoscope head where a disposable ear tip can be fixed for easy management of hygiene. The otoscope handle provides also a magnifying glass and integrated light to inspect the ear canal and the tympanic membrane without obstructing the stimulation. CoolStar is ideal when water can not be used for stimulation (tympanic membrane perforation, …), when water inlet and outlet are not available in the examination room and when ambient room temperature exceeds 22°C. Cool and warm air caloric stimulator Minimal temperature reachable: 10°C with water temperature in glass jar below 50°C Maximal temperature reachable: 49,8°C Air flow: fixed, from 8 to 10l/min, without ear tip Timer: Five stimulation times are available: 40, 60, 80,100 and 120s Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process. Glass jar with connection for demineralized water, holder and connections

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):	Yes
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?
34891	Diagnostic caloric vestibular stimulation system	An assembly of devices intended to evaluate a patient’s vestibular function through the application of heat and/or cold stimuli in the form of a stream of air or water into the ear canal, whereby involuntary horizontal eye movements (nystagmus) are produced and measured using a nystagmograph. The procedure may also be referred to as caloric reflex test, and is typically used for assessing a patient's balance system and/or to test for brainstem death. It typically consists of an irrigation system that includes a pump, valves, heaters and regulators to control the rate of flow and temperature of the medium. This device is typically used in an ear/nose/throat (ENT) department.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHH	Stimulator, Caloric-Air

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 30 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 55 Degrees Celsius
Handling Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 11.5 Centimeter
Depth: 45.5 Centimeter
Length: 31 Centimeter
Weight: 5 Kilogram

Device Record Status

Public Device Record Key: 28e1203c-c337-4468-aa7e-9c49827dc830
Public Version Date: November 19, 2020
Public Version Number: 2
DI Record Publish Date: September 17, 2018