FDA UDI
In Commercial Distribution
🇺🇸 United States
Cardea 20/20 ECG
DI: 00857553006016
·
Model: CS-2020-B
·
CARDIAC INSIGHT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cardea 20/20 ECG
- Primary DI
- 00857553006016
- Version / Model
- CS-2020-B
- Catalog Number
- CS-2020-B
- Company Name
- CARDIAC INSIGHT, INC.
- Labeler DUNS
- 827419834
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-24
- Public Version
- 1
- Public Version Date
- 2023-09-01
- Public Version Status
- New
- Public Device Record Key
- 34c95838-6e9d-469e-bd15-32c45cf8ae24
Device Description
Cardea 20/20 ECG is a portable ECG recorder designed for collection of resting (non-ambulatory) ECG data with software used for subsequent analysis of the patient's ECG data.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16231 | Electrocardiograph, professional, multichannel | A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857553006016 | GS1 |
Customer Contacts
- Phone
- 2065962060
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123217 | 000 |