BreathID Hp Lab System

GUDID 07290016923070

The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 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 Lab 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 Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application

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 ID	07290016923070
NIH Device Record Key	80d12571-b25c-4a80-b4f2-de8ea16ac346
Commercial Distribution Status	In Commercial Distribution
Brand Name	BreathID Hp Lab System
Version Model Number	VS01082
Company DUNS	514832786
Company Name	MERIDIAN BIOSCIENCE ISRAEL LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram
Height	16 Inch
Width	15 Inch
Depth	22 Inch
Weight	15 Kilogram
Height	10 Inch
Width	15.7 Inch
Depth	18 Inch
Weight	9 Kilogram

Operating and Storage Conditions

Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 102 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016923070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173777

FDA Product Code

MSQ	Test, Urea (Breath Or Blood)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-12-23
Device Publish Date	2021-12-15

Devices Manufactured by MERIDIAN BIOSCIENCE ISRAEL LTD

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07290016923278 - BreathID Smart System refurbished	2023-04-19 The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, wh
07290016923346 - BreathID Smart System	2023-04-19 The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, wh
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00350402100137 - IDKIT: HP ONE	2021-12-23 The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient
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