FDA UDI
In Commercial Distribution
🇺🇸 United States
Noxturnal Web
DI: 15694311112075
·
Model: NOXTURNAL_WEB
·
Nox Medical ehf.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Noxturnal Web
- Primary DI
- 15694311112075
- Version / Model
- NOXTURNAL_WEB
- Company Name
- Nox Medical ehf.
- Labeler DUNS
- 365741462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-05
- Public Version
- 1
- Public Version Date
- 2025-06-13
- Public Version Status
- New
- Public Device Record Key
- c39a624f-07e5-4b04-ac94-3bedf727e246
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
- No
- 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 |
|---|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64938 | Sleep disorder interpretive software, professional-only | An interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15694311112075 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241288 | 000 |