NIOX 12-2850-US

GUDID 07350047030700

Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (500). Also contains sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient.

Circassia AB

Nitrogen monoxide analyser

• Primary Device ID: 07350047030700
• NIH Device Record Key: 9231a4cb-e54a-4173-af2b-b3980e622ecc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIOX
• Version Model Number: NIOX VERO Test Kit 500
• Catalog Number: 12-2850-US
• Company DUNS: 632700860
• Company Name: Circassia AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com
• Phone: 1 866 275-6469
• Email: regulatory@circassia.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350047030700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133898

FDA Product Code

• MXA: System, Test, Breath Nitric Oxide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-05
• Device Publish Date: 2021-10-28

On-Brand Devices [NIOX]

• 07350047030519: NIOX Apps / Panel is an optional software accessory allowing an additional display for the NIOX
• 07350047030496: Disposable patient filter for use with the NIOX VERO device to be changed for each new measureme
• 07350047030472: NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in
• 07350047030038: Disposable filter (NIOX Filter) to be changed for each new measurement session and for each new
• 07350047030175: The NIOX VERO is supplied with an exchangeable handle accessory, to which the patient filter is
• 07350047030106: The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor
• 07350047030120: NIOX MINO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in so
• 07350047030380: The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor
• 07350047030366: This is a rechargeable Li-Ion replacement battery for the NIOX VERO that is charged via the powe
• 07350047030298: The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor
• 07350047030281: The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor
• 07350047030274: The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor
• 07350047030267: The NO sensor for NIOX VERO utilizes analytical electrochemical sensor technology. The NO sensor
• 07350047030168: The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor
• 07350047030113: The NO Scrubber for the NIOX MINO device eliminates ambient NO that is inhaled by the patient, a
• 07350047030076: The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor
• 07350047030069: The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor
• 07350047030052: The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor
• 07350047030717: Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO
• 07350047030700: Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO
• 07350047030694: Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO
• 07350047030687: Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO
• 07350047030670: Contains One NIOX VERO device, one sensor pre-programmed for a defined number of tests that is p
• 07350047030663: Contains One NIOX VERO device, one sensor pre-programmed for a defined number of tests that is p