Spare part: Vivatmo pro handheld US F09G100602

GUDID 04059233000130

Bosch Healthcare Solutions GmbH

Electrochemical breath analyser IVD, point-of-care

• Primary Device ID: 04059233000130
• NIH Device Record Key: e237a18c-efcd-40b5-97b2-49bd9ec0d84f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spare part: Vivatmo pro handheld US
• Version Model Number: F09G100602
• Catalog Number: F09G100602
• Company DUNS: 341189007
• Company Name: Bosch Healthcare Solutions GmbH
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059233000130 [Direct Marking]
GS1	04059233002813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233775

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

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