Gastrolyzer GASTROCEHCK-US

GUDID 05060246860375

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

BEDFONT SCIENTIFIC LIMITED

Multiple gas analyser
Primary Device ID05060246860375
NIH Device Record Key150eb625-d977-452e-b2e0-b4392fab0f77
Commercial Distribution StatusIn Commercial Distribution
Brand NameGastrolyzer
Version Model NumberGastroCHECK
Catalog NumberGASTROCEHCK-US
Company DUNS293959094
Company NameBEDFONT SCIENTIFIC LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060246860375 [Primary]

FDA Product Code

LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-20
Device Publish Date2020-03-12

On-Brand Devices [Gastrolyzer]

05060246860375Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.
05060246860153The Hydrogenius® product is a breath Hydrogen monitor used to measure hydrogen levels in expire
05060246860108The Gastro+™ Gastrolyzer® product is a breath Hydrogen monitor used to measure hydrogen level

Trademark Results [Gastrolyzer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GASTROLYZER
GASTROLYZER
79199538 5332059 Live/Registered
Bedfont Scientific Limited
2016-07-07

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