AccessGUDID - DEVICE: ATMOS (04250365142297)

GUDID

Device Identifier (DI) Information

Brand Name: ATMOS
Version or Model: Hygrotherm plus
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ATMOS MedizinTechnik GmbH & Co. KG

Primary DI Number: 04250365142297
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 319591939 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46323	Ear canal lavage system	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETP	Stimulator, Caloric-Water

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f9d82648-9e34-42c9-84ae-f94c19af0690
Public Version Date: December 05, 2024
Public Version Number: 1
DI Record Publish Date: November 27, 2024