BreathID Hp System VS01000

GUDID 07290016923056

The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.

MERIDIAN BIOSCIENCE ISRAEL LTD

Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD Infrared spectrometry breath analyser IVD
Primary Device ID07290016923056
NIH Device Record Key14ec947e-7ee9-423f-ab02-f1afc8a198c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreathID Hp System
Version Model NumberVS01000
Catalog NumberVS01000
Company DUNS514832786
Company NameMERIDIAN BIOSCIENCE ISRAEL LTD
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram
Height16 Inch
Width15 Inch
Depth22 Inch
Weight15 Kilogram

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016923056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSQTest, Urea (Breath Or Blood)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-23
Device Publish Date2021-12-15

On-Brand Devices [BreathID Hp System]

07290016923056The BreathID® Hp System is intended for use to continually and non-invasively measure changes i
07290016923148The BreathID® Hp System is intended for use to continually and non-invasively measure changes i

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