FDA.reportPublic FDA data

Vivatmo pro Oxycap

Primary DI
04059233000048
Brand
Vivatmo pro Oxycap
Company
Bosch Healthcare Solutions GmbH
Model
F09G100152
Catalog number
F09G100152
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
04059233000048PrimaryGS10
04059233000260Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059233000048040592330000484059233000048
04059233000260040592330002604059233000260

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
50
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
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
04059233002813Spare part: Vivatmo pro handheld USBosch Healthcare Solutions GmbHMXA2024-07-08
04059233002820Spare part: Vivatmo pro base station USBosch 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