AccessGUDID - DEVICE: ATMOS (04250365143065)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 04250365143065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 319591939 *Terms of Use

Device Description: Compact device for the dry thermal examination of the vestibular organ. Characteristics: Electronically controlled air calorisator with two temperature levels to be selected, preparation mode, stimulation mode (cold or warm stimulation depending on the preselected temperature), heating off and no airflow (saving mode, standby).

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?
34891	Diagnostic caloric vestibular stimulation system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHH	Stimulator, Caloric-Air

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: b52ba0c4-5fb4-4f21-bd38-18a1ce4300c1
Public Version Date: December 05, 2024
Public Version Number: 1
DI Record Publish Date: November 27, 2024