Identity
- Trade Name
- NIOX FDA UDI
- Generic Name
- Patient health record information system application software FDA UDI
- Device Name
- NIOX Apps / Panel is an optional software accessory allowing an additional display for the NIOX serise of Airway Inflammation Monitors including the NIOX MINO 09 and NIOX VERO devices. FDA UDI
- Model / Reference
- Apps / Panel FDA UDI
- Description
- NIOX Apps / Panel is an optional software accessory allowing an additional display for the NIOX serise of Airway Inflammation Monitors including the NIOX MINO 09 and NIOX VERO devices. FDA UDI
Identifiers
- Catalog Number
- 12-1004 FDA UDI
- Primary DI / UDI-DI
- 07350047030519 FDA UDI
- 510(k) Number
- K123683 FDA UDI
- FDA Product Code
- MXA FDA UDI
- GMDN Term
- Patient health record information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3080 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient health record information system application software
Niox by Circassia AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Circassia AB
Sources (1)
- FDA UDI 4e2b2d7a-8d8f-4099-8d95-b53a21ecda17 36 fields · synced Jun 8, 2026