CardeaScreen CS-2020-A
GUDID 00857553006009
CardeaScreen 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.
CARDIAC INSIGHT, INC.
Electrocardiograph, professional, multichannel| Primary Device ID | 00857553006009 |
| NIH Device Record Key | 8728783c-20cd-423a-be62-03807f71253a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CardeaScreen |
| Version Model Number | CS-2020-A |
| Catalog Number | CS-2020-A |
| Company DUNS | 827419834 |
| Company Name | CARDIAC INSIGHT, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857553006009 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123217
FDA Product Code
| DPS | Electrocardiograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-08-06 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by CARDIAC INSIGHT, INC.
| 00857553006016 - Cardea 20/20 ECG | 2023-09-01 Cardea 20/20 ECG is a portable ECG recorder designed for collection of resting (non-ambulatory) ECG data with software used for |
| 10857553006112 - Cardea SOLO | 2019-11-08 Cardea SOLO Wearable Sensor (M300) |
| 00857553006122 - Cardea SOLO | 2019-11-08 Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300). |
| 00857553006139 - Cardea SOLO | 2019-11-08 Cardea SOLO PC Software - ECG analysis software (D300) |
| 20857553006072 - Stealth System S300 | 2019-11-08 Stealth System Wearable Sensor (M300). |
| 00857553006092 - Stealth System S300 | 2019-11-08 StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300). |
| 00857553006009 - CardeaScreen | 2019-08-06CardeaScreen 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. |
| 00857553006009 - CardeaScreen | 2019-08-06 CardeaScreen is a portable ECG recorder designed for collection of resting (non-ambulatory) ECG data with software used for subs |
Trademark Results [CardeaScreen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDEASCREEN 85335302 4335458 Dead/Cancelled |
Cardea Associates, Inc. 2011-06-01 |
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