NIOX

Basic Information

• Brand Name: NIOX
• Primary DI: 07350047030700
• Version / Model: NIOX VERO Test Kit 500
• Catalog Number: 12-2850-US
• Company Name: Circassia AB
• Labeler DUNS: 632700860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-28
• Public Version: 1
• Public Version Date: 2021-11-05
• Public Version Status: New
• Public Device Record Key: 9231a4cb-e54a-4173-af2b-b3980e622ecc

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	862.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60354	Nitrogen monoxide analyser	An electrically-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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350047030700	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K133898	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 50 – 95 Degrees Fahrenheit