AccessGUDID - DEVICE: Gastrolyzer (05060246860153)

GUDID

Device Identifier (DI) Information

Brand Name: Gastrolyzer
Version or Model: HydroGenius
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LMTH2
Company Name: BEDFONT SCIENTIFIC LIMITED

Primary DI Number: 05060246860153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 293959094 *Terms of Use

Device Description: The Hydrogenius® 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRH	System, Breath Measurement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 71217c21-0e34-4320-b1ee-288af70bcbdf
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 2023