FDA.reportPublic FDA data

Spare part: Vivatmo pro handheld US

Primary DI
04059233002813
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

Product Codes#

Code, Name table
CodeName
MXASystem, Test, Breath Nitric Oxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXASystem, Test, Breath Nitric OxideClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233775000Vivatmo proBosch Healthcare Solutions GmbH2024-02-22MXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059233000130Direct MarkingGS10
04059233002813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059233000130040592330001304059233000130
04059233002813040592330028134059233002813

GMDN Terms#

Term, Definition table
TermDefinition
Electrochemical breath analyser IVD, point-of-careAn 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
TypeLowHighCondition
Handling Environment Atmospheric Pressure78 KiloPascal110 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius27 Degrees Celsius
Special Storage Condition, Specify00Keep dry
Storage Environment Humidity10 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius27 Degrees Celsius

Regulatory Flags#

DUNS number
341189007
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059233002820Spare part: Vivatmo pro base station USF09G100603F09G1006032024-07-08
04059233000048Vivatmo pro OxycapF09G100152F09G1001522024-07-08
04059233000307Vivatmo pro Level 0F09G100230F09G1002302024-07-08
04059233001274Vivatmo proF09G100510F09G1005102024-07-08
04059233000130Spare part: Vivatmo pro handheld USF09G100602F09G1006022024-07-08
04059233000123Spare part: Vivatmo pro base station USF09G100603F09G1006032024-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060246860191NObreath®BEDFONT SCIENTIFIC LIMITEDMXA2026-03-09
04059233002820Spare part: Vivatmo pro base station USBosch Healthcare Solutions GmbHMXA2024-07-08
04059233000048Vivatmo pro OxycapBosch Healthcare Solutions GmbHMXA2024-07-08
04059233000307Vivatmo pro Level 0Bosch Healthcare Solutions GmbHMXA2024-07-08
04059233001274Vivatmo proBosch Healthcare Solutions GmbHMXA2024-07-08
04059233000130Spare part: Vivatmo pro handheld USBosch Healthcare Solutions GmbHMXA2024-07-08
04059233000123Spare part: Vivatmo pro base station USBosch Healthcare Solutions GmbHMXA2024-07-08
00860008017901CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
00860008017918CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
00860008017925CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
00860008017932CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
00860008017949CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
00860008017956CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
05060246860177NOBreathBEDFONT SCIENTIFIC LIMITEDMXA2022-01-06
05060246860320FeNOBreathBEDFONT SCIENTIFIC LIMITEDMXA2022-01-06
07350047030663NIOXCircassia ABMXA2021-10-28
07350047030670NIOXCircassia ABMXA2021-10-28
07350047030687NIOXCircassia ABMXA2021-10-28
07350047030694NIOXCircassia ABMXA2021-10-28
07350047030700NIOXCircassia ABMXA2021-10-28
07350047030717NIOXCircassia ABMXA2021-10-28
07350047030458NIOXCircassia ABMXA2016-09-21
07350047030465NIOXCircassia ABMXA2016-09-21
07350047030052NIOXCircassia ABMXA2016-09-21
07350047030069NIOXCircassia ABMXA2016-09-21
07350047030076NIOXCircassia ABMXA2016-09-21
07350047030106NIOXCircassia ABMXA2016-09-21
07350047030113NIOXCircassia ABMXA2016-09-21
07350047030168NIOXCircassia ABMXA2016-09-21
07350047030175NIOXCircassia ABMXA2016-09-21