Dream Sock App
- Primary DI
- 00810099090819
- Brand
- Dream Sock App
- Company
- Owlet Baby Care Inc.
- Model
- 3.0
- Device description
- Dream Sock Software App. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
- Published
- 2024-02-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| QYU | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QYU | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use | Cardiovascular | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| DEN220091 | 000 | Dream Sock | Owlet Babycare, Inc. | 2023-11-08 | QYU |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810099090819 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00810099090819 | 00810099090819 | 810099090819 | 0810099090819 |
GMDN Terms
| Term | Definition |
|---|
| Multiple vital physiological parameter monitoring system, home-use | An assembly of electrically-powered devices designed to be used by a layperson in the home for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body. |
Regulatory Flags
- DUNS number
- 079422657
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false