AccessGUDID - DEVICE: NightWare (00860005400706)

GUDID

Device Identifier (DI) Information

Brand Name: NightWare
Version or Model: 100001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nightware Incorporated

Primary DI Number: 00860005400706
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080783807 *Terms of Use

Device Description: The NightWare device includes a software application and the NightWare server. The device uses an Apple Watch® and an Apple iPhone® for its platform. These components monitor your sleep behavior and, using a proprietary formula, creates a unique sleep profile to help you get a better night’s sleep. NightWare is designed to monitor your heart rate and movement throughout the night and occasionally provide vibrotactile interventions (haptic feedback) through the Apple Watch while you are sleeping. These interventions will occur when NightWare detects that you have exceeded a certain threshold and will disrupt the phenomena consistent with a nightmare at the time that it is occurring. The first night you use NightWare, the watch will not provide any of these interventions because it is gathering enough data to create your unique sleep profile. The data that NightWare collects from the Apple Watch includes: Heart Rate, Body Movement (Acceleration),Body Position (Rotation). This information is securely sent to the NightWare servers and processed to help you improve the quality of your sleep.

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:	Yes
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?
64939	Sleep disorder interpretive software, patient-use	An interpretive software program intended to be installed on an off-the-shelf smartphone/tablet for use by a patient/layperson in the home to record and analyse patient physiological data collected during sleep using a home-use device (e.g., CPAP/BPAP unit therapy analyser, microphone), for self-analysis of sleep/sleep therapy. It may be used to assist a patient to refine their sleep therapy, or to better understand their sleep behaviour, and might in addition be intended to assist a healthcare professional to treat/understand a sleep disorder.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QMZ	Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 86f56e56-686d-463a-a4c5-36a282e25f99
Public Version Date: March 23, 2022
Public Version Number: 1
DI Record Publish Date: March 15, 2022