DEVICE: NIOX (07350047030366)
Device Identifier (DI) Information
NIOX
VERO Battery
In Commercial Distribution
12-1150
Circassia AB
VERO Battery
In Commercial Distribution
12-1150
Circassia AB
This is a rechargeable Li-Ion replacement battery for the NIOX VERO that is charged via the power supply or USB port.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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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 50 and 107 KiloPascal |
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6cbcc3b3-1075-44ed-9d7d-fb10ff0840d4
December 04, 2020
6
September 21, 2016
December 04, 2020
6
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