Identity
- Trade Name
- NIOX FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- Disposable patient filter for use with the NIOX VERO device to be changed for each new measurement session and for each new patient. FDA UDI
- Model / Reference
- VERO Filter FDA UDI
- Description
- Disposable patient filter for use with the NIOX VERO device to be changed for each new measurement session and for each new patient. FDA UDI
Identifiers
- Catalog Number
- 12-1018 FDA UDI
- Primary DI / UDI-DI
- 07350047030496 FDA UDI
- 510(k) Number
- K133898 FDA UDI
- FDA Product Code
- MXA FDA UDI
- GMDN Term
- Pulmonary function testing filter/mouthpiece 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary function testing filter/mouthpiece
Niox by Circassia AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 2cfaf860-e011-41fa-99ae-a4bdb4c12730 37 fields · synced Jun 6, 2026