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 tips 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.By default, temperature values are 27°C, 30°C, 44°C and 47°C.Five stimulation times are available: 40, 60, 80,100 and 120sWarm air caloric stimulatorMinimal temperature reachable: 5°C over the ambient temperatureMaximal temperature reachable: 48°CAir flow: fixed, from 10 to 13l/min, without ear tipTimerIntended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to thecaloric testing process.
Catalog Number
31013
Brand Name
Instrumentation Difra SA
Version/Model Number
AirStar 115V
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KHH
Product Code Name
Stimulator, Caloric-Air
Public Device Record Key
c78c184d-0ad8-4e67-93fc-7bdf0cdae01d
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |