{"publicDeviceRecordKey":"28e1203c-c337-4468-aa7e-9c49827dc830","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2020-11-19T00:00:00.000Z","devicePublishDate":"2018-09-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B51617481","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Instrumentation Difra","versionModelNumber":"CoolStar 230V 3.0","catalogNumber":"17481","dunsNumber":"370173410","companyName":"Instrumentation Difra SA","deviceCount":1,"deviceDescription":"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. \nThe vestibular stimulation of the semicircular canals produces involuntary eye movements.\nThe 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.\nCoolStar is ideal when water can not be used for stimulation (tympanic membrane perforation, …), when water inlet and outlet are not available in the examination room and when ambient room temperature exceeds 22°C.\nCool and warm air caloric stimulator\nMinimal temperature reachable: 10°C with water temperature in glass jar below 50°C\nMaximal temperature reachable: 49,8°C\nAir flow: fixed, from 8 to 10l/min, without ear tip\nTimer: Five stimulation times are available: 40, 60, 80,100 and 120s\nIntended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process.\nGlass jar with connection for demineralized water, holder and connections","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":true,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"260.436.1436","phoneExtension":null,"email":"dbscherer@gmail.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34891","gmdnPTName":"Diagnostic caloric vestibular stimulation system","gmdnPTDefinition":"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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KHH","productCodeName":"Stimulator, Caloric-Air"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Height","size":{"unit":"Centimeter","value":"11.5"},"sizeText":null,"sizeString":"Height: 11.5 Centimeter"},{"sizeType":"Depth","size":{"unit":"Centimeter","value":"45.5"},"sizeText":null,"sizeString":"Depth: 45.5 Centimeter"},{"sizeType":"Length","size":{"unit":"Centimeter","value":"31"},"sizeText":null,"sizeString":"Length: 31 Centimeter"},{"sizeType":"Weight","size":{"unit":"Kilogram","value":"5"},"sizeText":null,"sizeString":"Weight: 5 Kilogram"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"90"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"30"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"90"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"30"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"55"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"5"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"35"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"5"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}