Cardea 20/20 ECG CS-2020-B

GUDID 00857553006016

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.

CARDIAC INSIGHT, INC.

Electrocardiograph, professional, multichannel

• Primary Device ID: 00857553006016
• NIH Device Record Key: 34c95838-6e9d-469e-bd15-32c45cf8ae24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardea 20/20 ECG
• Version Model Number: CS-2020-B
• Catalog Number: CS-2020-B
• 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

• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com
• Phone: 2065962060
• Email: info@cardiacinsightinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857553006016 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-01
• Device Publish Date: 2023-08-24

Devices Manufactured by CARDIAC INSIGHT, INC.

• 00857553006016 - Cardea 20/20 ECG: 2023-09-01Cardea 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.
• 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
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• 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: 2019-08-06 CardeaScreen is a portable ECG recorder designed for collection of resting (non-ambulatory) ECG data with software used for subs