gudid
Primary ID: NObreath Mouthpiece
NObreath (UDI NObreath Mouthpiece)
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 Mouthpiece
Device Regulatory Overview
The NObreath (Model/Catalog Number: NObreath Mouthpiece) 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 Mouthpiece
- Product Code / EMDN
- MXA
- Device Name
- Designed specifically for the NObreath FeNO monitor, the NObreath mouthpiece (FeNObreath Mouthpiece) contains an integrated infection control filter that removes and traps >99% of airborne bacteria and >98% of viruses.The NObreath mouthpiece (FeNObreath Mouthpiece) may be used multiple times by one patient, per clinical visit.NOTE: The NObreath mouthpiece (FeNObreath Mouthpiece) is a single-patient use; re-use of the mouthpiece between patients can increase the risk of cross-inflection and result in incorrect readings.
- 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 Mouthpiece.
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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