Instrumentation Difra

Basic Information

• Brand Name: Instrumentation Difra
• Primary DI: B51617550
• Version / Model: AquaStar 115V 2.0
• Catalog Number: 17550
• Company Name: Instrumentation Difra SA
• Labeler DUNS: 370173410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-17
• Public Version: 2
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: 040d8c91-089b-48ba-9be1-0f7e681bfb5a

Device Description

The water caloric stimulator is a device that delivers a stream of water 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. An internal chronometer offers through a second rotary switch the possibility to select the stimulation time. Five stimulation times are available: 20, 30, 40,50 and 60s By default, temperature values are 27°C, 30°C, 37°C and 44°C. Minimal temperature reachable: 3°C over the ambient temperature Maximal temperature reachable: 48°C Water flow: fixed, 350ml/min Timer Requires a water supply and an outlet Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process.

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
ETP	Stimulator, Caloric-Water	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	B51617550	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	11.5	Centimeter
Depth	35.5	Centimeter
Length	31	Centimeter
Weight	5	Kilogram

Storage Conditions

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