AccessGUDID - DEVICE: Noxturnal APP (15694311110019)

GUDID

Device Identifier (DI) Information

Brand Name: Noxturnal APP
Version or Model: NOX-NOXTURNAL_APP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 536210
Company Name: Nox Medical ehf.

Primary DI Number: 15694311110019
Issuing Agency: GS1
Commercial Distribution End Date: October 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 365741462 *Terms of Use

Device Description: No description.

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:	No
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?
64938	Sleep disorder interpretive software, professional-only	An interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
KZM	Device, Muscle Monitoring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192469	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e2dd240-5db7-4b2c-a4d8-71c9b7e98073
Public Version Date: October 24, 2022
Public Version Number: 4
DI Record Publish Date: February 24, 2020