AccessGUDID - DEVICE: NIOX (07350047030458)

GUDID

Device Identifier (DI) Information

Brand Name: NIOX
Version or Model: MINO 09
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09-1100
Company Name: Circassia AB

Primary DI Number: 07350047030458
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 632700860 *Terms of Use

Device Description: NIOX MINO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX MINO according to guidelines for NO measurement established by the American Thoracic Society.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60354	Nitrogen monoxide analyser	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MXA	System,Test,Breath Nitric Oxide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101034	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -5 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d593c30e-db13-4969-bf1e-ecd422b8ef23
Public Version Date: December 04, 2020
Public Version Number: 6
DI Record Publish Date: September 21, 2016