FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Dreem 2
DI: 00850010086019
·
Model: EFM00MD
·
DREEM
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Dreem 2
- Primary DI
- 00850010086019
- Version / Model
- EFM00MD
- Company Name
- DREEM
- Labeler DUNS
- 266283476
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-18
- Public Version
- 2
- Public Version Date
- 2023-06-30
- Public Version Status
- Update
- Public Device Record Key
- ec6e82d5-4446-4bb6-bade-184285510044
- Distribution End Date
- 2020-12-18
Device Description
Dreem 2 is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep and a mobile application. Dreem 2 is intended to aid in relaxing and falling asleep and to generate reports, advices and contents to help the user better understand his or her sleep, and take steps to improve it.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63697 | Psychophysiological biofeedback system | A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850010086019 | GS1 |