NOBreath
Basic Information
- Brand Name
- NOBreath
- Primary DI
- 05060246860177
- Version / Model
- NOBreath V2
- Catalog Number
- NOBREATH-V2
- Company Name
- BEDFONT SCIENTIFIC LIMITED
- Labeler DUNS
- 293959094
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-06
- Public Version
- 1
- Public Version Date
- 2022-01-14
- Public Version Status
- New
- Public Device Record Key
- 076fcad4-8250-4868-802e-70478fef4716
Device Description
The NObreath® 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 NObreath® 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 NObreath® according to guidelines for NO measurement established by the American Thoracic Society. NObreath® is intended for children, 7- 17 years, and adults 18 years and older. NObreath® 12 second test mode is for age 7 and up NObreath® 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 NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation. NObreath® should not be used in critical care, emergency care or in anesthesiology.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MXA | System, Test, Breath Nitric Oxide | Clinical Toxicology | 862.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65453 | Nitric oxide breath analyser | An electrically-powered device intended to be used in a clinical setting to measure the concentration of nitric oxide (NO) exhaled by a patient using electrochemical analysis, typically to evaluate airway inflammation. It is typically a hand-held sensor unit with controls and display; a breathing mouthpiece may be included with the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060246860177 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203695 | 000 |