NightWare

Primary DI
00860005400706
Brand
NightWare
Company
Nightware Incorporated
Model
100001
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.
Published
2022-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric ConditionsNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005400706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005400706008600054007068600054007060860005400706

GMDN Terms#

Term, Definition table
TermDefinition
Sleep disorder interpretive software, patient-useAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080783807
Device count
1
Kit
true
Lot or batch
true
Serial number
true