BreathID Hp Lab Device

GUDID 07290016923384

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

• Primary Device ID: 07290016923384
• NIH Device Record Key: 7177d4f8-62a8-40ed-9ad4-cb0e2ef192f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BreathID Hp Lab Device
• Version Model Number: VS02000
• 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: false
• 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

Operating and Storage Conditions

• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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	07290016923384 [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: 2024-07-30
• Device Publish Date: 2024-07-22

Devices Manufactured by MERIDIAN BIOSCIENCE ISRAEL LTD

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• 07290016923384 - BreathID Hp Lab Device: 2024-07-30The 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
• 07290016923384 - BreathID Hp Lab Device: 2024-07-30 The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath,
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