NIOX 12-1018

GUDID 07350047030496

Disposable patient filter for use with the NIOX VERO device to be changed for each new measurement session and for each new patient.

Circassia AB

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 07350047030496
• NIH Device Record Key: 2cfaf860-e011-41fa-99ae-a4bdb4c12730
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIOX
• Version Model Number: VERO Filter
• Catalog Number: 12-1018
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350047030199 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	07350047030496 [Primary]
GS1	7350047030489 [Package]; Package: Box [20 Units]; In Commercial Distribution
GS1	7350047030502 [Package]; Contains: 7350047030489; Package: Case [15 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-09-21

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