FDA.reportPublic FDA data

Gastrolyzer

Primary DI
05060246860399
Brand
Gastrolyzer
Company
BEDFONT SCIENTIFIC LIMITED
Model
GastroGENIUS
Catalog number
LMTCH4
Device description
The GastroGENIUS® is a portable desktop monitor which measures hydrogen (H2), methane (CH4) and oxygen (O2) leaves in expired breath samples in response to appropriate substrates. It is intended to be for multi-patient use on children and adults and used by healthcare professionals primarily in a hospital, or physician's surgery.The expired breath can be delivered direct to the monitor for immediate analysis via a mouthpiece or a sample can be taken remotely via a breath-bag for subsequent analysis.The GastroGENIUS® will be used by a single patient at a time but will interface with a PC to allow a multi-patient sampling protocol to be performed. The GastroGENIUS® can be used as an aid to diagnose the following disorders:Carbohydrate breakdown deficiencyCarbohydrate malabsorptionLactose intolerance Bacterial overgrowthDetermination of time of passage through gutSpecific diagnosis is not possible with this device; further specific testing would need to be carried out to diagnose a patient's condition.
Published
2023-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NRHSystem, Breath Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRHSystem, Breath MeasurementClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060246860399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060246860399050602468603995060246860399

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gas breath analyserAn electrically-powered device intended to be used in a clinical setting to simultaneously measure the concentrations of two or more gases [e.g., hydrogen (H2), methane (CH4), oxygen (O2)] in an exhaled breath sample. It typically uses electrochemical analysis to assist with the diagnosis of various conditions (e.g., breakdown deficiency and/or malabsorption of carbohydrates, lactose intolerance). It is typically a desktop sensor unit with controls and display; a breathing mouthpiece and/or an exhaled-gas sample collector may be included with the device.

Regulatory Flags#

DUNS number
293959094
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060246860238D-Piece™D-Piece™D-PIECE-32026-03-17
05060246860474SteriBreath™ EcoSteriBreath™ Eco MouthpieceSTERIBREATH-ECO2026-03-17
05060246860191NObreath®NObreath® MouthpieceNOBREATH-V2-MP502026-03-09
05060246860368GastrolyzerGastroCHECKGASTROCHECK2024-09-05
05060246860108GastrolyzerGastro+GASTRO2023-06-08
05060246860153GastrolyzerHydroGeniusLMTH22023-06-08
05060246860375GastrolyzerGastroCHECKGASTROCEHCK-US2020-03-12
05060246860177NOBreathNOBreath V2NOBREATH-V22022-01-06
05060246860320FeNOBreathFeNOBreathFENOBREATH-MGC2022-01-06
05060246860429iCO Quit SmokerlyzeriCO QuitICOQUIT2022-01-06
05060246860030ToxCOToxCOTOXCO-USA2020-03-12
05060246860047SmokerlyzerMicro+MICROADV2020-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850010197999BT UPGRADE, CUI, INC POWER SUPPLIESQUINTRON INSTRUMENT COMPANY, INC.NRH2025-03-19
00860006377830Pure Comfort Breath ExerciserHOME AIDE DIAGNOSTICS, INC.NRH2024-10-08
10860006377837Pure Comfort Breath ExerciserHOME AIDE DIAGNOSTICS, INC.NRH2024-10-08
00850010197982SUGAR, Rx, LACTULOSE, 10 GM SYRUP, USPQUINTRON INSTRUMENT COMPANY, INC.NRH2024-03-18
05060246860108GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-08
05060246860153GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-08
00850010197937LOANER ALVEOVAC EXTRACTORQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-17
00850010197944EXTRACTOR REPAIRQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-17
00850010197906BT GC LOANER SCQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-16
00850010197913BREATHTRACKER SERIES REPAIRQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-16
00850010197234DUST BARRIER, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197272VIAL ADAPTER, PLASTIC, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197371STOPCOCK, ONE-WAY, PLASTICQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197210FILTER, FOAM PLUG, 10 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197227Patient Sample Drying TubeQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197869DUST BARRIER, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197265SX2 Plus Maintenance KitQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197876VIAL ADAPTER, PLASTIC, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197302Tank Support, Safety, Table-Top PlasticQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197357Drying Tube End, Sample Inlet, FemaleQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197364Drying Tube End, Sample Inlet, MaleQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197883STOPCOCK, ONE-WAY, PLASTICQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197395SivRite-4 Tubing AssemblyQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197418Screwdriver, Valve Removal ToolQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197456Extraction System Output TubingQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197500AlveoVac Exraction System-USA 24VDCQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197258BreathPrep DesiccantQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20
00850010197449BreathTrackerQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20
00850010197463BreathTrackerQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20