Gastrolyzer

Basic Information

• Brand Name: Gastrolyzer
• Primary DI: 05060246860108
• Version / Model: Gastro+
• Catalog Number: GASTRO
• Company Name: BEDFONT SCIENTIFIC LIMITED
• Labeler DUNS: 293959094
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 1
• Public Version Date: 2023-06-16
• Public Version Status: New
• Public Device Record Key: 620d4631-0467-413d-b864-94537d9d29b6

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRH	System, Breath Measurement	Clinical Chemistry	862.1820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65451	Hydrogen breath analyser	An electrically-powered device intended to be used in a clinical setting to measure the concentration of exhaled hydrogen (H2) in end-tidal breath using electrochemical analysis, typically to assist with the diagnosis of intolerance and/or malabsorption of carbohydrates and/or intestinal bacterial overgrowth. It consists of a hand-held sensor unit with controls, display, and a breathing mouthpiece; a face mask and/or filter may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060246860108	GS1