Gastrolyzer GASTROCEHCK-US

GUDID 05060246860375

Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.

BEDFONT SCIENTIFIC LIMITED

Multiple gas analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Multiple gas environmental analyser Ambient gas analyser Ambient gas analyser Ambient gas analyser Ambient gas analyser Ambient gas analyser Ambient gas analyser

• Primary Device ID: 05060246860375
• NIH Device Record Key: 150eb625-d977-452e-b2e0-b4392fab0f77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gastrolyzer
• Version Model Number: GastroCHECK
• Catalog Number: GASTROCEHCK-US
• Company DUNS: 293959094
• Company Name: BEDFONT SCIENTIFIC LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060246860375 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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

On-Brand Devices [Gastrolyzer]

• 05060246860375: Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.
• 05060246860153: The Hydrogenius® product is a breath Hydrogen monitor used to measure hydrogen levels in expire
• 05060246860108: The Gastro+™ Gastrolyzer® product is a breath Hydrogen monitor used to measure hydrogen level