FDA.reportPublic FDA data

Interacoustics

Primary DI
05711117199567
Brand
Interacoustics
Company
Interacoustics A/S
Model
Air Fx
Published
2021-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05711117199567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711117199567057111171995675711117199567

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306308354
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05711117230796Sanibel Supply A/SSanibel EARturtle Universal85372062026-05-14
05711117230802Sanibel Supply A/SSanibel EARturtle Universal Box of 36 kits w/tab e85372092026-05-14
05711117244304Sanibel Supply A/SSanibel EARturtle Universal Box of 36 kits w/snap 86025002026-05-14
05711117244991InteracousticsVisualEyes 5052025-08-14
05711117245004InteracousticsVisualEyes EyeSeeCam vHIT2025-08-14
05711117245028InteracousticsVisualEyes 5252025-08-14
05711117230833Sanibel Supply A/SER10C-0385372382025-08-07
05711117230840Sanibel Supply A/SER10C-0485372392025-08-07
05711117230857Sanibel Supply A/SER10C-0585372402025-08-07
05711117230864Sanibel Supply A/SER10C-0685372412025-08-07
05711117245097Sanibel Supply A/SER10C-0385372382025-08-07
05711117245103Sanibel Supply A/SER10C-0485372392025-08-07
05711117245110Sanibel Supply A/SER10C-0585372402025-08-07
05711117245127Sanibel Supply A/SER10C-0685372412025-08-07
05711117008395Sanibel SupplyEar tip, OAE-4 ER Infant, 4 mm red flanged2022-12-08
05711117226089Sanibel SupplyEar tip infant 4 mm, ANA-4.0, blue2022-12-08
05711117226096Sanibel SupplyEar tip infant 5 mm, ANA-5.0, green2022-12-08
05711117226102Sanibel SupplyEar tip infant 4,5 mm, ANA-4.5, red-brown2022-12-08
05711117226119Sanibel SupplyEar tip 5 mm, AOT-5.0 light blue2022-12-08
05711117226126Sanibel SupplyEar tip 4 mm, AOT-4.0 green2022-12-08

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
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