Instrumentation Difra

Basic Information

• Brand Name: Instrumentation Difra
• Primary DI: B516175530
• Version / Model: CoolStar 115V 3.0
• Catalog Number: 17553
• Company Name: Instrumentation Difra SA
• Labeler DUNS: 370173410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-18
• Public Version: 2
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: 6d6109c4-1a2e-4522-94cd-0a7709f45361

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KHH	Stimulator, Caloric-Air	Ear, Nose, Throat	874.1800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34891	Diagnostic caloric vestibular stimulation system	An assembly of devices intended to evaluate a patient’s vestibular function through the application of heat and/or cold stimuli in the form of a stream of air or water into the ear canal, whereby involuntary horizontal eye movements (nystagmus) are produced and measured using a nystagmograph. The procedure may also be referred to as caloric reflex test, and is typically used for assessing a patient's balance system and/or to test for brainstem death. It typically consists of an irrigation system that includes a pump, valves, heaters and regulators to control the rate of flow and temperature of the medium. This device is typically used in an ear/nose/throat (ENT) department.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B516175530	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	11.5	Centimeter
Length	31	Centimeter
Depth	45.5	Centimeter
Weight	5	Kilogram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 55 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity