FDA UDI
In Commercial Distribution
🇺🇸 United States
Empatica Health Monitoring Platform
DI: 00853858006249
·
Model: Care App iOS
·
EMPATICA SRL
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Empatica Health Monitoring Platform
- Primary DI
- 00853858006249
- Version / Model
- Care App iOS
- Company Name
- EMPATICA SRL
- Labeler DUNS
- 430141750
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-24
- Public Version
- 1
- Public Version Date
- 2022-12-02
- Public Version Status
- New
- Public Device Record Key
- 53f6d2e8-d8ef-4c0e-940a-929f54792f69
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
- 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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| GZO | Device, Galvanic Skin Response Measurement | Neurology | 882.1540 | 2 |
| LEL | Device, Sleep Assessment | Neurology | 882.5050 | 2 |
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65669 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853858006249 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221282 | 000 |