ATMOS

Primary DI
04250365142297
Brand
ATMOS
Company
ATMOS MedizinTechnik GmbH & Co. KG
Model
Hygrotherm plus
Device description
The product is used to clean the external auditory canal by flushing with water, for example to remove cerumen. For this purpose, the device is connected to a water connection, heats the water to body temperature and transfers it through a hose to a handle, which allows the targeted application of the water. A drain hose is used to drain water from the device in order to limit the life of the water in the device itself.
Published
2024-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ETPStimulator, Caloric-Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETPStimulator, Caloric-WaterEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250365142297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250365142297042503651422974250365142297

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal lavage systemA device assembly designed for automated or semi-automated irrigation, washing, and extraction of tissue and/or debris from the ear canal. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a vacuum extractor, a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the ear canal. The system is mainly intended to remove debris (typically cerumen) to clean the ear canal for hygienic purposes, to improve hearing, and before procedures and/or surgery in or through the ear canal.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
319591939
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
04250365195071ATMOSC 051 Thorax2025-03-25
04250365142273ATMOSVariotherm plus2024-11-27
04250365143065ATMOSVarioair2024-11-27
04250365149791ATMOSC 21 Economy - function column (230 V~)2024-11-27
04250365149807ATMOSC 21 Economy - function column (115 V~)2024-11-27
04250365149814ATMOSC 21 Economy - function column (127 V~)2024-11-27
04250365149821ATMOSC 31 Economy - function column (230 V~)2024-11-27
04250365149838ATMOSC 31 Economy - function column (115 V~)2024-11-27
04250365149845ATMOSC 31 Economy - function column (127 V~)2024-11-27
04250365155471ATMOSHL 21 LED2024-11-27
04250365155488ATMOSHL 21 LED (examination set)2024-11-27
04250365155495ATMOSHL 21 LED (OT set)2024-11-27
04250365155839ATMOSLS 21 LED2024-11-27
04250365155860ATMOSLS 21 LED set, white2024-11-27
04250365156034ATMOSStrobo 21 LED2024-11-27
04250365164084ATMOSS 61 Servant ENT workstation (230 V~)2024-11-27
04250365164107ATMOSS 61 Servant ENT workstation (115 V~)2024-11-27
04250365164114ATMOSS 61 Servant ENT workstation (127 V~)2024-11-27
04250365166187ATMOSS 61 Servant Vision2024-11-27
04250365167832ATMOSStrobo 21 LED (integrated in ATMOS S 61 Servant)2024-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250365142273ATMOSATMOS MedizinTechnik GmbH & Co. KGETP2024-11-27
05711117199574InteracousticsInteracoustics A/SETP2022-04-12
B516174730Instrumentation DifraInstrumentation Difra SAETP2020-05-18
B516175500Instrumentation DifraInstrumentation Difra SAETP2020-05-18
B51617473Instrumentation DifraInstrumentation Difra SAETP2018-09-17
B51617550Instrumentation DifraInstrumentation Difra SAETP2018-09-17