FDA UDI
In Commercial Distribution
🇺🇸 United States
DROWZLE Pro
DI: 00860004872405
·
Model: 2.0
·
RESONEA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DROWZLE Pro
- Primary DI
- 00860004872405
- Version / Model
- 2.0
- Company Name
- RESONEA, INC.
- Labeler DUNS
- 079132539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-04
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 6f8533f0-9916-4f37-be75-9f04f293ba35
Device Description
DROWZLE PRO is indicated to record a patient’s respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stastages, limb movements, or EEG activity are required
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| MNR | Ventilatory Effort Recorder | Anesthesiology | 868.2375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62230 | Home-use sleep apnoea recording system | A battery-powered device assembly intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort/pattern, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep apnoea [e.g., obstructive sleep apnoea (OSA)]. It includes primary components such as sensors (e.g., air pressure sensor) and/or a control unit which may have some user-interface functionality, and typically additional devices which may include a gas sampling face mask and/or connecting leads/cables; collected data is transferred to a central database or computerized device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860004872405 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173974 | 000 |