Instrumentation Difra 17473

GUDID B516174730

The water caloric stimulator is a device that delivers a stream of water 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. An internal chronometer offers through a second rotary switch the possibility to select the stimulation time. Five stimulation times are available: 20, 30, 40,50 and 60s By default, temperature values are 27°C, 30°C, 37°C and 44°C. Minimal temperature reachable: 3°C over the ambient temperature Maximal temperature reachable: 48°C Water flow: fixed, 350ml/min Timer Requires a water supply and an outlet Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process.

Instrumentation Difra SA

Caloric vestibular-stimulation system
Primary Device IDB516174730
NIH Device Record Key52db553a-80c6-448c-ad9d-badddcaec2e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstrumentation Difra
Version Model NumberAquaStar 230V 2.0
Catalog Number17473
Company DUNS370173410
Company NameInstrumentation Difra SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone260.436.1436
Emaildbscherer@gmail.com
Phone260.436.1436
Emaildbscherer@gmail.com
Phone260.436.1436
Emaildbscherer@gmail.com
Phone260.436.1436
Emaildbscherer@gmail.com
Phone260.436.1436
Emaildbscherer@gmail.com
Phone260.436.1436
Emaildbscherer@gmail.com
Phone260.436.1436
Emaildbscherer@gmail.com
Phone260.436.1436
Emaildbscherer@gmail.com
Phone260.436.1436
Emaildbscherer@gmail.com
Phone260.436.1436
Emaildbscherer@gmail.com
Phone260.436.1436
Emaildbscherer@gmail.com

Device Dimensions

Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Depth35.5 Centimeter
Length31 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB516174730 [Primary]

FDA Product Code

ETPStimulator, Caloric-Water

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-26
Device Publish Date2020-05-18

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