NIOX 02-1201

GUDID 07350047030038

Disposable filter (NIOX Filter) to be changed for each new measurement session and for each new patient and an accessory to the NIOX MINO 09

Circassia AB

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 07350047030038
• NIH Device Record Key: 27133ff7-d38b-4371-bcb2-6f36f4cff76b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIOX
• Version Model Number: MINO Filter
• Catalog Number: 02-1201
• 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 Temperature: Between -5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350047030038 [Package]; Contains: 07350047030465; Package: Box [50 Units]; In Commercial Distribution
GS1	07350047030045 [Package]; Contains: 07350047030465; Package: Box [100 Units]; In Commercial Distribution
GS1	07350047030465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101034

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