gudid
Primary ID: NOBreath V2
NOBreath (UDI NOBreath V2)
Manufactured by BEDFONT SCIENTIFIC LIMITED
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NOBreath - Primary ID NOBreath V2
Device Regulatory Overview
The NOBreath (Model/Catalog Number: NOBreath V2) is a medical device manufactured by BEDFONT SCIENTIFIC LIMITED. This product is indexed under FDA Product Code / Category Classification MXA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- NOBreath V2
- Product Code / EMDN
- MXA
- Device Name
- 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 upNObreath 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.
- Database Sync Date
- 2026-08-09 09:57:34
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of NOBreath?
The registered manufacturer of record for NOBreath is BEDFONT SCIENTIFIC LIMITED.
What is the Primary UDI-DI identifier for NOBreath?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is NOBreath V2.
What classification code is assigned to this device?
This device is registered under product classification code MXA.
Similar Classification Devices (MXA)
Other Devices by BEDFONT SCIENTIFIC LIMITED
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