BreathID Smart System

GUDID 07290016923223

The BreathID® Smart 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® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart 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 ID: 07290016923223
• NIH Device Record Key: ada64117-c04f-4dcd-991d-83fb07a109f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BreathID Smart System
• Version Model Number: VS07000
• 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: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram
• Height: 16 Inch
• Width: 15 Inch
• Depth: 22 Inch
• Weight: 15 Kilogram

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016923223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193610

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

On-Brand Devices [BreathID Smart System]

• 07290016923223: The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/1
• 07290016923353: The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/1
• 07290016923346: The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/1