NightWare
Basic Information
- Brand Name
- NightWare
- Primary DI
- 00860005400706
- Version / Model
- 100001
- Company Name
- Nightware Incorporated
- Labeler DUNS
- 080783807
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-15
- Public Version
- 1
- Public Version Date
- 2022-03-23
- Public Version Status
- New
- Public Device Record Key
- 86f56e56-686d-463a-a4c5-36a282e25f99
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QMZ | Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions | Neurology | 882.5705 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860005400706 | GS1 |