Genio System 2.1
Basic Information
- Brand Name
- Genio System 2.1
- Primary DI
- 05404031000001
- Version / Model
- Genio Implantable Stimulator Model #2954 with Surgical Template
- Catalog Number
- NX-PKG-002954
- 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
- c019996a-34b4-4a62-a9ac-b19fab10fdde
Device Description
The Implantable Stimulator Model #2954 is a single-use, sterile, small saddle-shaped implant that delivers stimulation to both hypoglossal nerve branches (i.e. left and right). The body of the Implantable Stimulator consists of an energy receiving antenna and an electrical circuit both encapsulated in a ceramic housing, and two lateral legs with a pair of paddle electrodes. It is powered and controlled by either the Activation Chip or External Stimulator externally. The Implantable Stimulator does not include a battery or a microcontroller or software. Packaged with the Implantable Stimulator Model #2954 is the Surgical Template. The Surgical Template is a single use, sterile accessory which can be optionally used for preparation of the implantation site.
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 | 05404031000001 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240024 | 000 |