FDA.reportPublic FDA data

NIOX

Primary DI
07350047030120
Brand
NIOX
Company
Circassia AB
Model
MINO 09
Catalog number
09-1100
Device description
NIOX MINO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fraction
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K101034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101034000NIOX MINO MODEL 09-1000Aerocrine AB2010-09-02MXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350047030120PackageGS11In Commercial Distribution
07350047030458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350047030120073500470301207350047030120
07350047030458073500470304587350047030458

GMDN Terms#

Term, Definition table
TermDefinition
Nitrogen monoxide analyserA mains electricity (AC-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 Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Fahrenheit140 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
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
false
Expiration date on label
true
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 DIBrandModelCatalogPublished
07350047030663NIOXNIOX VERO Starter Kit 10012-1810-US2021-10-28
07350047030670NIOXNIOX VERO Starter Kit 30012-1830-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

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
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