Vivatmo pro Level 0 F09G100230

GUDID 04059233000307

Disposable mouthpiece for Vivatmo

Bosch Healthcare Solutions GmbH

Electrochemical breath analyser filter/mouthpiece IVD

• Primary Device ID: 04059233000307
• NIH Device Record Key: a90df9b6-610d-4f17-bf6c-aef0237c70ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivatmo pro Level 0
• Version Model Number: F09G100230
• Catalog Number: F09G100230
• Company DUNS: 341189007
• Company Name: Bosch Healthcare Solutions GmbH
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059233000277 [Unit of Use]
GS1	04059233000307 [Primary]

FDA Product Code

• MXA: System, Test, Breath Nitric Oxide

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: 2024-07-16
• Device Publish Date: 2024-07-08

Devices Manufactured by Bosch Healthcare Solutions GmbH

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• 04059233000307 - Vivatmo pro Level 0: 2024-07-16 Disposable mouthpiece for Vivatmo
• 04059233001274 - Vivatmo pro: 2024-07-16 Vivatmo pro Nitric Oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human brea
• 04059233000130 - Spare part: Vivatmo pro handheld US: 2024-07-16
• 04059233000123 - Spare part: Vivatmo pro base station US: 2024-07-16