Instrumentation Difra 17553

GUDID B51617553

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

Instrumentation Difra SA

Caloric vestibular-stimulation system
Primary Device IDB51617553
NIH Device Record Key6e18f423-a3b8-4ef8-963d-b33310a5a009
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstrumentation Difra
Version Model NumberCoolStar 115V 3.0
Catalog Number17553
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

Device Dimensions

Height11.5 Centimeter
Length31 Centimeter
Depth45.5 Centimeter
Weight5 Kilogram
Height11.5 Centimeter
Length31 Centimeter
Depth45.5 Centimeter
Weight5 Kilogram

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB51617553 [Primary]

FDA Product Code

KHHStimulator, Caloric-Air

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-18
Device Publish Date2018-09-17

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