FDA UDI
In Commercial Distribution
🇺🇸 United States
Genio System 2.1
DI: 05404031000049
·
Model: Genio Smartphone Application Software
·
Nyxoah
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Genio System 2.1
- Primary DI
- 05404031000049
- Version / Model
- Genio Smartphone Application Software
- Company Name
- Nyxoah
- Labeler DUNS
- 400460590
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-26
- Public Version
- 1
- Public Version Date
- 2025-09-03
- Public Version Status
- New
- Public Device Record Key
- 8edd5aad-b623-4334-a05a-97509cca512e
Device Description
The Activation Chip can be controlled by an optional Genio Smartphone Application software, designed to operate on both Android and iOS devices. The Smartphone Application software allows the patient to pause and resume stimulation and to increase/decrease the treatment amplitude within a pre-configured range. The Smartphone Application software uses Bluetooth low energy (BLE) protocol to communicate with a paired Activation Chip.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60360 | Implantable sleep apnoea treatment system, fixed-rate | An assembly of devices intended for home management of obstructive sleep apnoea (OSA) using an implanted stimulator to provide fixed-rate electrical stimulation to the hypoglossal nerve [targeted hypoglossal nerve stimulation (THN)]. It may take two forms: 1) an implanted pulse generator with implanted lead and electrode cuff with a portable patient-operated remote controller/charger; or 2) an unpowered stimulator with paddle electrodes with an external battery-powered control unit which supplies power telemetrically to the implant. It will include dedicated application software used by a healthcare professional for device configuration. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05404031000049 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240024 | 000 |