FDA UDI
In Commercial Distribution
🇺🇸 United States
Genio System 2.1
DI: 05404031018693
·
Model: Genio External Stimulator
·
Nyxoah
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Genio System 2.1
- Primary DI
- 05404031018693
- Version / Model
- Genio External Stimulator
- Catalog Number
- NX-PKG-001869
- 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
- a368e32e-d447-4e22-8770-a697d154454b
Device Description
The External Stimulator is a single-use, sterile accessory that allows the surgeon to activate the Implantable Stimulator and verify the functionality of the implant during the surgical procedure. The External Stimulator contains a power button with an LED indicator, a pre-charged battery and a retractable scaling mechanism to control the stimulation intensity delivered to the implant.
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
- Labeling does not contain MRI Safety Information
- 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 | 05404031018693 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240024 | 000 |