FDA.reportPublic FDA data

Gastrolyzer

Primary DI
05060246860368
Brand
Gastrolyzer
Company
BEDFONT SCIENTIFIC LIMITED
Model
GastroCHECK
Catalog number
GASTROCHECK
Device description
Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.
Published
2024-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060246860368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060246860368050602468603685060246860368

GMDN Terms#

Term, Definition table
TermDefinition
Ambient gas analyserAn 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.

Regulatory Flags#

DUNS number
293959094
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration 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
05060246860399GastrolyzerGastroGENIUSLMTCH42023-06-15
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

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Primary DI, Brand, Company table
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00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022005Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022012Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022050Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022067Helmer ScientificHELMER, INC.LXG2026-05-13
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00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050559KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050603KBMEDKB Medical (group), Inc.LXG2025-05-22
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20885380197861CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18