Air Caloric Irrigator

Primary DI
06980291491135
Brand
Air Caloric Irrigator
Company
ISEN Tech. & Trading Co., Ltd.
Model
AirC
Device description
The AirC is an air caloric stimulator intended to deliver controlled warm or cool air to the external ear canal for caloric vestibular stimulation during vestibular function testing.
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHHStimulator, Caloric-Air

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHHStimulator, Caloric-AirEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06980291491135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06980291491135069802914911356980291491135

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic caloric vestibular stimulation systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1-954-591-9309sliu@isen.com.cn

Regulatory Flags#

DUNS number
527141254
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B499V060ISEN-GogglesV062017-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250365143065ATMOSATMOS MedizinTechnik GmbH & Co. KGKHH2024-11-27
B516310120Instrumentation Difra SAInstrumentation Difra SAKHH2022-09-28
B516310130Instrumentation Difra SAInstrumentation Difra SAKHH2022-09-28
05713315009235ICSNatus Medical Denmark ApSKHH2021-07-06
05713315009242ICSNatus Medical Denmark ApSKHH2021-07-06
05713315009259ICSNatus Medical Denmark ApSKHH2021-07-06
05713315009266ICSNatus Medical Denmark ApSKHH2021-07-06
05711117199567InteracousticsInteracoustics A/SKHH2021-06-14
B516174810Instrumentation DifraInstrumentation Difra SAKHH2020-05-18
B516174850Instrumentation DifraInstrumentation Difra SAKHH2020-05-18
B516175530Instrumentation DifraInstrumentation Difra SAKHH2020-05-18
05713315002533GN Otometrics A/SNatus Medical Denmark ApSKHH2019-04-24
B51617481Instrumentation DifraInstrumentation Difra SAKHH2018-09-17
B51617485Instrumentation DifraInstrumentation Difra SAKHH2018-09-17
B51617553Instrumentation DifraInstrumentation Difra SAKHH2018-09-17
05713315004124GN Otometrics A/SNatus Medical Denmark ApSKHH2016-09-19
05713315004131GN Otometrics A/SNatus Medical Denmark ApSKHH2016-09-19