CorVista® System
- Primary DI
- 00869059000429
- Brand
- CorVista® System
- Company
- Analytics For Life Inc
- Model
- 10-0020
- Device description
- CorVista® System with CAD Add-On
- Published
- 2024-02-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| QXX | Coronary Artery Disease machine learning-based notification software |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QXX | Coronary Artery Disease Machine Learning-Based Notification Software | Cardiovascular | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K232686 | 000 | CorVista® System | Corvista Health, Inc. | 2023-09-08 | QXX |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00869059000429 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00869059000429 | 00869059000429 | 869059000429 | 0869059000429 |
GMDN Terms
| Term | Definition |
|---|
| Multiparameter physiologic analysis workstation | A computerized unit intended to be used with a variety of noninvasive sensors (not included) for the non-continuous measurement of a variety of cardiovascular and pulmonary parameters [e.g., blood pressure, electrocardiography (ECG), SpO2, lung volume, airway resistance]; it might also be intended for additional physiologic analysis [e.g., electromyography (EMG), galvanic skin response (GSR)]. It includes sensor inputs, controls (e.g., touchscreen) and is intended to allow viewing, sharing and storage of the data; it is neither intended for continuous monitoring nor stress exercise monitoring. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Atmospheric Pressure | 50 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 5 Percent (%) Relative Humidity | 95 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -20 Degrees Celsius | 45 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 208050922
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00869059000436 | CorVista® System with CAD Add-On | CorVista System with CAD Add-On | | 2024-04-19 |
| 00869059000443 | CorVista® System with PH Add-On | CorVista System with PH Add-On | | 2024-04-19 |
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