Home GUDID 04059233000130 Spare part: Vivatmo pro handheld US
Primary DI 04059233000130
Brand Spare part: Vivatmo pro handheld US
Company Bosch Healthcare Solutions GmbH
Model F09G100602
Catalog number F09G100602
Published 2024-07-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name MXA System, Test, Breath Nitric Oxide
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MXA System, Test, Breath Nitric Oxide Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04059233000130 Direct Marking GS1 0 04059233002813 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04059233000130 04059233000130 4059233000130 04059233002813 04059233002813 4059233002813
GMDN Terms# Term, Definition table Term Definition 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).
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 78 KiloPascal 110 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 60 Percent (%) Relative Humidity Handling Environment Temperature 15 Degrees Celsius 27 Degrees Celsius Special Storage Condition, Specify 0 0 Keep dry Storage Environment Humidity 10 Percent (%) Relative Humidity 60 Percent (%) Relative Humidity Storage Environment Temperature 5 Degrees Celsius 27 Degrees Celsius
Regulatory Flags# DUNS number 341189007 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04059233002813 Spare part: Vivatmo pro handheld US F09G100602 F09G100602 2024-07-08 04059233002820 Spare part: Vivatmo pro base station US F09G100603 F09G100603 2024-07-08 04059233000048 Vivatmo pro Oxycap F09G100152 F09G100152 2024-07-08 04059233000307 Vivatmo pro Level 0 F09G100230 F09G100230 2024-07-08 04059233001274 Vivatmo pro F09G100510 F09G100510 2024-07-08 04059233000123 Spare part: Vivatmo pro base station US F09G100603 F09G100603 2024-07-08
Other Devices Sharing Product Codes#