Vivatmo pro

Basic Information

• Brand Name: Vivatmo pro
• Primary DI: 04059233001274
• Version / Model: F09G100510
• Catalog Number: F09G100510
• Company Name: Bosch Healthcare Solutions GmbH
• Labeler DUNS: 341189007
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-08
• Public Version: 1
• Public Version Date: 2024-07-16
• Public Version Status: New
• Public Device Record Key: 737d3619-ad82-4aad-8b79-5c2ec4322009

Device Description

Vivatmo pro Nitric Oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	862.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64516	Electrochemical breath analyser IVD, point-of-care	An electrically-powered point-of-care instrument designed to use electrochemical analysis for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a specimen of air exhaled from a patient. It is used to measure analytes associated with various conditions [e.g., COVID-19 SARS-CoV-2 antigens, hydrogen peroxide (H2O2) as an indicator of inflammation and/or oxidative stress in the airways related to asthma and chronic obstructive pulmonary disorder (COPD)]. It is typically a hand-held or portable instrument, which requires additional consumables such as electrochemical electrode sensors/cartridges and mouthpieces/valves (not included).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04059233001274	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 27 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 78 – 110 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 15 – 27 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 60 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry