FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Axon
DI: 09413000078442
·
Model: Medium
·
EXSURGO LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Axon
- Primary DI
- 09413000078442
- Version / Model
- Medium
- Catalog Number
- 100160
- Company Name
- EXSURGO LIMITED
- Labeler DUNS
- 594916540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-13
- Public Version
- 2
- Public Version Date
- 2025-01-15
- Public Version Status
- Update
- Public Device Record Key
- addbc680-7454-48ca-a2ef-e3df7033c69e
- Distribution End Date
- 2024-03-31
Device Description
Neurofeedback Kit - Medium includes Axon EEG headset - Medium, Tablet with Axon Neurofeedback Software Application
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63697 | Psychophysiological biofeedback system | A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09413000078442 | GS1 |
Customer Contacts
- Phone
- +642183583
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 55 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 131 Degrees Fahrenheit