Gastrolyzer

Basic Information

• Brand Name: Gastrolyzer
• Primary DI: 05060246860375
• Version / Model: GastroCHECK
• Catalog Number: GASTROCEHCK-US
• Company Name: BEDFONT SCIENTIFIC LIMITED
• Labeler DUNS: 293959094
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-12
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 150eb625-d977-452e-b2e0-b4392fab0f77

Device Description

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

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36320	Ambient gas analyser	An electrically-powered device intended to measure the concentration of one or more gas(es) [e.g., oxygen (O2), carbon dioxide (CO2)] from the ambient environment (e.g., within a room), typically to monitor the work conditions of employees. It is typically a hand-held or wearable sensor unit with controls and display.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060246860375	GS1