Identity
- Trade Name
- NIOX FDA UDI
- Generic Name
- Nitrogen monoxide analyser FDA UDI
- Device Name
- NIOX MINO 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 MINO according to guidelines for NO measurement established by the American Thoracic Society. FDA UDI
- Model / Reference
- MINO 09 FDA UDI
- Description
- NIOX MINO 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 MINO according to guidelines for NO measurement established by the American Thoracic Society. FDA UDI
Identifiers
- Catalog Number
- 09-1100 FDA UDI
- Primary DI / UDI-DI
- 07350047030458 FDA UDI
- 510(k) Number
- K101034 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
K101034 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 d593c30e-db13-4969-bf1e-ecd422b8ef23 37 fields · synced May 30, 2026