Gastrolyzer GASTRO

GUDID 05060246860108

The Gastro+™ Gastrolyzer® product is a breath Hydrogen monitor used to measure hydrogen levels in expired breath. It is intended for multi-patient use by healthcare professionals in a clinical environment.

BEDFONT SCIENTIFIC LIMITED

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• Primary Device ID: 05060246860108
• NIH Device Record Key: 620d4631-0467-413d-b864-94537d9d29b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gastrolyzer
• Version Model Number: Gastro+
• Catalog Number: GASTRO
• 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: false
• 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	05060246860108 [Primary]

FDA Product Code

• NRH: System, Breath Measurement

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: 2023-06-16
• Device Publish Date: 2023-06-08

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