Smokerlyzer MICROADV

GUDID 05060246860047

The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient use by healthcare professionals in smoking cessation programmes and research. The Micro+™ Smokerlyzer® product can also be used as an indicator of carbon monoxide poisoning in a healthcare environment.

BEDFONT SCIENTIFIC LIMITED

Carbon monoxide breath analyser

• Primary Device ID: 05060246860047
• NIH Device Record Key: 1688502e-6ae1-4937-ae95-c5a887aa7bcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smokerlyzer
• Version Model Number: Micro+
• Catalog Number: MICROADV
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060246860047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082315

FDA Product Code

• CCJ: Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

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: 2020-03-20
• Device Publish Date: 2020-03-12

Devices Manufactured by BEDFONT SCIENTIFIC LIMITED

• 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: 2020-03-20The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient use by healthcare professionals in smoking cessation programmes and research. The Micro+™ Smokerlyzer® product can also be used as an indicator of carbon monoxide poisoning in a healthcare environment.
• 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.