NIOX

Basic Information

• Brand Name: NIOX
• Primary DI: 07350047030465
• Version / Model: MINO Filter
• Catalog Number: 02-1201
• Company Name: Circassia AB
• Labeler DUNS: 632700860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2019-02-13
• Public Version Status: Update
• Public Device Record Key: 27133ff7-d38b-4371-bcb2-6f36f4cff76b

Device Description

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

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
61097	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07350047030038	GS1	Box	50	In Commercial Distribution
Primary	07350047030465	GS1
Package	07350047030045	GS1	Box	100	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101034	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -5 – 140 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity