FDA UDI
In Commercial Distribution
🇺🇸 United States
ATMOS
DI: 04250365143065
·
Model: Varioair
·
ATMOS MedizinTechnik GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ATMOS
- Primary DI
- 04250365143065
- Version / Model
- Varioair
- Company Name
- ATMOS MedizinTechnik GmbH & Co. KG
- Labeler DUNS
- 319591939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-27
- Public Version
- 1
- Public Version Date
- 2024-12-05
- Public Version Status
- New
- Public Device Record Key
- b52ba0c4-5fb4-4f21-bd38-18a1ce4300c1
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHH | Stimulator, Caloric-Air | Ear, Nose, Throat | 874.1800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250365143065 | GS1 |