NObreath®

Basic Information

• Brand Name: NObreath®
• Primary DI: 05060246860191
• Version / Model: NObreath® Mouthpiece
• Catalog Number: NOBREATH-V2-MP50
• Company Name: BEDFONT SCIENTIFIC LIMITED
• Labeler DUNS: 293959094
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-09
• Public Version: 1
• Public Version Date: 2026-03-17
• Public Version Status: New
• Public Device Record Key: 82eec1b2-1b6c-429a-9eab-41fd36689a27

Device Description

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.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
44545	Breathing mouthpiece, single-use	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060246860191	GS1

Premarket Submissions

Submission Number	Supplement Number
K203695	000