Identity
- Trade Name
- NIOX FDA UDI
- Generic Name
- Nitrogen monoxide analyser FDA UDI
- Device Name
- NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society. FDA UDI
- Model / Reference
- VERO FDA UDI
- Description
- NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society. FDA UDI
Identifiers
- Catalog Number
- 12-1000 FDA UDI
- Primary DI / UDI-DI
- 07350047030472 FDA UDI
- 510(k) Number
- K133898 FDA UDI
- FDA Product Code
- MXA FDA UDI
- GMDN Term
- Nitrogen monoxide analyser 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nitrogen monoxide analyser
Niox by Circassia AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrogen monoxide analyser.
- NIOX — Circassia AB · Class II
- NIOX — Circassia AB · Class II
- NIOX — Circassia AB · Class II
- NIOX — Circassia AB · Class II
- NIOX — Circassia AB · Class II
- NIOX — Circassia AB · Class II
- NIOX — Circassia AB · Class II
- NIOX — Circassia AB · Class II
Cleared under the same submission
K133898 also covers:
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 801da88f-d1b4-4e09-91c4-501f6097ac3f 37 fields · synced May 30, 2026