AccessGUDID - DEVICE: NIOX (07350047030465)

GUDID

Device Identifier (DI) Information

Brand Name: NIOX
Version or Model: MINO Filter
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02-1201
Company Name: Circassia AB

Primary DI Number: 07350047030465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 632700860 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MXA	System,Test,Breath Nitric Oxide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101034	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -5 and 140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 27133ff7-d38b-4371-bcb2-6f36f4cff76b
Public Version Date: February 13, 2019
Public Version Number: 4
DI Record Publish Date: September 21, 2016