Identity
- Trade Name
- Instrumentation Difra FDA UDI
- Generic Name
- Diagnostic caloric vestibular stimulation system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CoolStar 230V 3.0 FDA UDI
- 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 , when water inlet and outlet are not available in the examination room and when ambient room temperature exceeds 22 C. FDA UDI
Identifiers
- Catalog Number
- 17481 FDA UDI
- Primary DI / UDI-DI
- B516174810 FDA UDI
- FDA Product Code
- KHH FDA UDI
- GMDN Term
- Diagnostic caloric vestibular stimulation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.1800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 11.5 Centimeter FDA UDIDepth — 45.5 Centimeter FDA UDILength — 31 Centimeter FDA UDIWeight — 5 Kilogram FDA UDI
Category: Diagnostic caloric vestibular stimulation system
Instrumentation Difra by Instrumentation Difra SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Diagnostic caloric vestibular stimulation system.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Difra SA
Sources (1)
- FDA UDI 56fd1a25-728d-4056-af31-9316901568d8 37 fields · synced May 30, 2026