DEVICE: NIOX (07350047030496)

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Device Identifier (DI) Information

NIOX
VERO Filter
12-1018
Aerocrine AB
07350047030496
GS1
1
Disposable patient filter for use with the NIOX VERO device to be changed for each new measurement session and for each new patient.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Pulmonary function testing filter/mouthpiece A non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.
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FDA Product Code

[?]
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

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
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

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
7350047030489 20 07350047030496 In Commercial Distribution Box
7350047030502 15 7350047030489 In Commercial Distribution Case
07350047030199 5 In Commercial Distribution Box
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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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1 (866) 275-6469
service.us@aerocrine.com
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