BreathID Smart System

GUDID 07290016923346

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

• Primary Device ID: 07290016923346
• NIH Device Record Key: 4373e740-960b-4068-8a60-f275bb630c05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BreathID Smart System
• Version Model Number: VS07000W
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016923346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193610
• Premarket Notification: K223185

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: 2023-04-19
• Device Publish Date: 2023-04-11

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