DEVICE: NIOX (07350047030175)

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Device Identifier (DI) Information

NIOX
VERO Handle
12-1010
Aerocrine AB
07350047030175
GS1
1
The NIOX VERO is supplied with an exchangeable handle accessory, to which the patient filter is attached and contains the NO scrubber filter. The handle should be exchanged by the user every 1000 measurement or after one year of use.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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.
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FDA Product Code

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

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 107 KiloPascal
Storage Environment Temperature: between -5 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 21, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
No
No CLOSE

Customer Contact

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1 (866) 275-6469
service.us@aerocrine.com
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