Identity
- Trade Name
- NIOX FDA UDI
- Generic Name
- Nitrogen monoxide analyser FDA UDI
- Device Name
- Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (500). Also contains sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient. FDA UDI
- Model / Reference
- NIOX VERO Test Kit 500 FDA UDI
- Description
- Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (500). Also contains sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient. FDA UDI
Identifiers
- Catalog Number
- 12-2850-US FDA UDI
- Primary DI / UDI-DI
- 07350047030700 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
No
FDA UDI
Expiration Date
No
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Circassia AB
Sources (1)
- FDA UDI 9231a4cb-e54a-4173-af2b-b3980e622ecc 37 fields · synced May 30, 2026