NObreath® NOBREATH-V2-MP50

GUDID 05060246860191

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.

BEDFONT SCIENTIFIC LIMITED

Breathing mouthpiece, single-use

• Primary Device ID: 05060246860191
• NIH Device Record Key: 82eec1b2-1b6c-429a-9eab-41fd36689a27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NObreath®
• Version Model Number: NObreath® Mouthpiece
• Catalog Number: NOBREATH-V2-MP50
• Company DUNS: 293959094
• Company Name: BEDFONT SCIENTIFIC LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060246860191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203695

FDA Product Code

• MXA: System, Test, Breath Nitric Oxide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-17
• Device Publish Date: 2026-03-09

Devices Manufactured by BEDFONT SCIENTIFIC LIMITED

• 05060246860191 - NObreath®: 2026-03-17Designed 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.
• 05060246860191 - NObreath®: 2026-03-17 Designed specifically for the NObreath® FeNO monitor, the NObreath® mouthpiece (FeNObreath Mouthpiece) contains an integrated
• 05060246860108 - Gastrolyzer: 2023-06-16 The Gastro+™ Gastrolyzer® product is a breath Hydrogen monitor used to measure hydrogen levels in expired breath. It is inten
• 05060246860153 - Gastrolyzer: 2023-06-16 The Hydrogenius® product is a breath Hydrogen monitor used to measure hydrogen levels in expired breath. It is intended for mul
• 05060246860030 - ToxCO: 2020-03-20 The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Monoxide (CO) poisoning and calculation of the Carbo
• 05060246860047 - Smokerlyzer: 2020-03-20 The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient use by healthcare professiona
• 05060246860375 - Gastrolyzer: 2020-03-20 Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.