DEVICE: NIOX (07350047030274)
Device Identifier (DI) Information
NIOX
VERO Sensor 300
In Commercial Distribution
12-1630
Circassia AB
VERO Sensor 300
In Commercial Distribution
12-1630
Circassia AB
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
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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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
[?]Product Code | Product Code Name |
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MXA | System,Test,Breath Nitric Oxide |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K133898 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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
[?]Size Type Text |
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No Device Sizes |
Device Record Status
96e71e07-ca5b-4f9b-b3d4-253cb7c17e2b
February 14, 2019
5
September 21, 2016
February 14, 2019
5
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1 (866) 275-6469
Regulatory@circassia.com
Regulatory@circassia.com