ATMOS

GUDID 04250365142273

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.

ATMOS MedizinTechnik GmbH & Co. KG

Diagnostic caloric vestibular stimulation system

• Primary Device ID: 04250365142273
• NIH Device Record Key: 9d422241-eef6-4516-837a-075437f9e978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATMOS
• Version Model Number: Variotherm plus
• Company DUNS: 319591939
• Company Name: ATMOS MedizinTechnik GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250365142273 [Primary]

FDA Product Code

• ETP: Stimulator, Caloric-Water

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-05
• Device Publish Date: 2024-11-27

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