Instrumentation Difra - The air caloric stimulator is a device that - Instrumentation Difra SA

Duns Number:370173410

Device Description: The air caloric stimulator is a device that delivers a stream of air to the ear canal at c 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 , when water inlet and outlet are not available in the examination room and when ambient room temperature exceeds 22 C.

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More Product Details

Catalog Number

17481

Brand Name

Instrumentation Difra

Version/Model Number

CoolStar 230V 3.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KHH

Product Code Name

Stimulator, Caloric-Air

Device Record Status

Public Device Record Key

56fd1a25-728d-4056-af31-9316901568d8

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

May 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSTRUMENTATION DIFRA SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 8