ToxCO TOXCO-USA

GUDID 05060246860030

The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Monoxide (CO) poisoning and calculation of the Carboxyhaemoglobin (COHb) level. The ToxCO Breath Carbon Monoxide Monitor can be used by healthcare professionals in medical institutions, emergency medical services where Carbon Monoxide exposure is suspected for paediatric, adult, and unconscious patients.

BEDFONT SCIENTIFIC LIMITED

Carbon monoxide breath analyser

• Primary Device ID: 05060246860030
• NIH Device Record Key: a1438018-131d-4061-b72e-8658e5bbbb84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ToxCO
• Version Model Number: ToxCO
• Catalog Number: TOXCO-USA
• 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	05060246860030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173238

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: 2020-03-20The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Monoxide (CO) poisoning and calculation of the Carboxyhaemoglobin (COHb) level. The ToxCO Breath Carbon Monoxide Monitor can be used by healthcare professionals in medical institutions, emergency medical services where Carbon Monoxide exposure is suspected for paediatric, adult, and unconscious patients.
• 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.