AccessGUDID - DEVICE: NIOX (07350047030274)

GUDID

Device Identifier (DI) Information

Brand Name: NIOX
Version or Model: VERO Sensor 300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12-1630
Company Name: Aerocrine AB

Primary DI Number: 07350047030274
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 632700860 *Terms of Use

Device Description: The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 60，100，300，500 or 1000 tests.

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Nitrogen monoxide analyser	A 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.

GMDN Preferred Term Name

GMDN Definition

Nitrogen monoxide analyser

A 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.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133898	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

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Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 107 KiloPascal
Storage Environment Temperature: between -4 and 77 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 99 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96e71e07-ca5b-4f9b-b3d4-253cb7c17e2b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016