Identity
- Trade Name
- Nox C1s Kit FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Model / Reference
- NOX-C1SKIT1_US FDA UDI
Identifiers
- Catalog Number
- 544024 FDA UDI
- Primary DI / UDI-DI
- 15694311111597 FDA UDI
- 510(k) Number
- K192469 FDA UDI
- FDA Product Code
- OLZ FDA UDIKZM FDA UDI
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI890.1375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Polysomnograph
Nox C1s Kit by Nox Medical ehf. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192469 also covers:
- Nox A1 Carry Case — Nox Medical ehf.
- Nox A1 Recorder — Nox Medical ehf.
- Nox A1 Starter Sensor Kit, Adult — Nox Medical ehf.
- Nox A1 Starter Sensor Kit, Pediatric — Nox Medical ehf.
- Nox A1 System — Nox Medical ehf.
- Nox A1s Recorder — Nox Medical ehf.
- Nox A1® EEG 5 Lead Gold Electrode Cable — Nox Medical ehf.
- Nox A1® EEG Head Cable — Nox Medical ehf.
- Nox C1 Access Point — Nox Medical ehf.
- Nox C1 Kit — Nox Medical ehf.
- Nox C1 Kit — Nox Medical ehf.
- Noxturnal PSG CD — Nox Medical ehf.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nox Medical ehf.
Sources (1)
- FDA UDI 5bc253f0-2dfc-477f-a8ac-ee585e5cf204 35 fields · synced May 31, 2026