Identity
- Trade Name
- FeNOBreath FDA UDI
- Generic Name
- Nitric oxide breath analyser FDA UDI
- Device Name
- The FeNObreath is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by FeNObreath is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels. The fractional NO concentration in expired breath (FeNO), can be measured by FeNObreath according to guidelines for NO measurement established by the American Thoracic Society. FeNObreath is intended for children, 7- 17 years, and adults 18 years and older. FeNObreath 12 second test mode is for age 7 and up FeNObreath 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test. FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The FeNObreath cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation. FeNObreath should not be used in critical care, emergency care or in anesthesiology. FDA UDI
- Model / Reference
- FeNOBreath FDA UDI
- Description
- The FeNObreath is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by FeNObreath is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels. The fractional NO concentration in expired breath (FeNO), can be measured by FeNObreath according to guidelines for NO measurement established by the American Thoracic Society. FeNObreath is intended for children, 7- 17 years, and adults 18 years and older. FeNObreath 12 second test mode is for age 7 and up FeNObreath 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test. FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The FeNObreath cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation. FeNObreath should not be used in critical care, emergency care or in anesthesiology. FDA UDI
Identifiers
- Catalog Number
- FENOBREATH-MGC FDA UDI
- Primary DI / UDI-DI
- 05060246860320 FDA UDI
- 510(k) Number
- K203695 FDA UDI
- FDA Product Code
- MXA FDA UDI
- GMDN Term
- Nitric oxide breath 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitric oxide breath analyser
FeNOBreath by Bedfont Scientific Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Bedfont Scientific Limited
Sources (1)
- FDA UDI 2eb0e3ef-2445-49fb-8258-2f006619b784 35 fields · synced May 30, 2026