Vivatmo pro Level 0

Primary DI
04059233000307
Brand
Vivatmo pro Level 0
Company
Bosch Healthcare Solutions GmbH
Model
F09G100230
Catalog number
F09G100230
Device description
Disposable mouthpiece for Vivatmo
Published
2024-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059233000307PrimaryGS10
04059233000277Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059233000307040592330003074059233000307
04059233000277040592330002774059233000277

GMDN Terms#

Term, Definition table
TermDefinition
Electrochemical breath analyser filter/mouthpiece IVDA device designed as a breathing mouthpiece and filter intended to be attached to an in vitro diagnostic electrochemical breath analyser to facilitate exhaled air specimen sampling and accurate measurement of target chemical and/or biological markers. It has an integrated reactive filtering material to remove potentially confounding species (e.g., ammonia, methanol) and to chemically prepare the specimen for measurement [e.g., via oxidation]; it may also be designed to remove target particles to provide a control baseline measurement. This is a single-use device.

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 Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341189007
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059233002813Spare part: Vivatmo pro handheld USF09G100602F09G1006022024-07-08
04059233002820Spare part: Vivatmo pro base station USF09G100603F09G1006032024-07-08
04059233000048Vivatmo pro OxycapF09G100152F09G1001522024-07-08
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
04059233002813Spare part: Vivatmo pro handheld USBosch Healthcare Solutions GmbHMXA2024-07-08
04059233002820Spare part: Vivatmo pro base station USBosch Healthcare Solutions GmbHMXA2024-07-08
04059233000048Vivatmo pro OxycapBosch 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