FDA UDI
In Commercial Distribution
🇺🇸 United States
ICS
DI: 05713315009259
·
Model: 8-04-13320
·
Gn Otometrics A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ICS
- Primary DI
- 05713315009259
- Version / Model
- 8-04-13320
- Company Name
- Gn Otometrics A/S
- Labeler DUNS
- 306633756
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-06
- Public Version
- 1
- Public Version Date
- 2021-07-14
- Public Version Status
- New
- Public Device Record Key
- 70f145ae-1758-424c-a313-ad98619bcf45
Device Description
AirCal Caloric Stimulator, Extended (Extended length - 4m)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 | 05713315009259 | GS1 |