FDA.reportPublic FDA data

NIOX

Primary DI
07350047030670
Brand
NIOX
Company
Circassia AB
Model
NIOX VERO Starter Kit 300
Catalog number
12-1830-US
Device description
Contains One NIOX VERO device, one sensor pre-programmed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (300) and sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient.
Published
2021-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K133898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133898000NIOX VERO AIRWAY INFLAMMATION MONITORAerocrine AB2014-11-06MXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350047030670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350047030670073500470306707350047030670

GMDN Terms#

Term, Definition table
TermDefinition
Nitrogen monoxide analyserAn electrically-powered device intended to measure nitric oxide (NO), also known as nitrogen monoxide, in exhaled air to facilitate diagnosis and management of asthma. Measurements are used to calculate fractional exhaled nitric oxide (FeNO) at different levels of the respiratory tract (e.g., bronchial, alveolar, nasal). It typically consists of a software-controlled, electronic unit and an attached tube for collection of expired air. It may also provide spirometry measurements.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 866 275-6469regulatory@circassia.com

Regulatory Flags#

DUNS number
632700860
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350047030663NIOXNIOX VERO Starter Kit 10012-1810-US2021-10-28
07350047030687NIOXNIOX VERO Test Kit 10012-2810-US2021-10-28
07350047030694NIOXNIOX VERO Test Kit 30012-2830-US2021-10-28
07350047030700NIOXNIOX VERO Test Kit 50012-2850-US2021-10-28
07350047030717NIOXNIOX VERO Test Kit 100012-2900-US2021-10-28
07350047030458NIOXMINO 0909-11002016-09-21
07350047030052NIOXMINO Sensor 5003-20052016-09-21
07350047030069NIOXMINO Sensor 10003-20102016-09-21
07350047030076NIOXMINO Sensor 30003-20302016-09-21
07350047030106NIOXMINO Sensor 100003-21002016-09-21
07350047030113NIOXMINO NO Scrubber09-13002016-09-21
07350047030168NIOXMINO Sensor 50003-20502016-09-21
07350047030175NIOXVERO Handle12-10102016-09-21
07350047030267NIOXVERO Sensor 10012-16102016-09-21
07350047030274NIOXVERO Sensor 30012-16302016-09-21
07350047030281NIOXVERO Sensor 50012-16502016-09-21
07350047030298NIOXVERO Sensor 100012-17002016-09-21
07350047030366NIOXVERO Battery12-11502016-09-21
07350047030380NIOXVERO Sensor 6012-16062016-09-21
07350047030472NIOXVERO12-10002016-09-21

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
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
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