PEERBRIDGE HEALTH, INC.

Address:3 Columbus Circle,New York,NY,10019,US

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- Catalog Number : COREVENT

Device Description : COREVENTThe Peerbridge Cor™ System is a family of products comprised of two mode COREVENTThe Peerbridge Cor™ System is a family of products comprised of two models, thePeerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). Thesystem is an ambulatory wearable ECG monitoring system designed to record andprovide patient's electrocardiogram (ECG) data to the clinician.The Peerbridge System consists of five components: (1) Wearable ECG Sensor withBluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld TransmitterDevice, (4) Data Upload Fixture and Software that allow ECG data to be uploaded fromthe Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-basedBackend Data Management Module. The Wearable ECG sensor attaches to the patient'schest and records the patient's ECG continuously. This device can collect two (2)channels and 3-leads of ECG data continuously for up to seven (7) days. In addition,patients can report symptomatic events by pressing the Event Button on the WearableECG Sensor or by using the mobile application on the Handheld Transmitter when asymptom is experienced. The device generates ECG reports to be displayed on theclinician's interface.The Peerbridge System Cor Event is configured for the following:- 24 hours of Holter monitoring - Patient Activated Event with Surveillance

Device Class :

Duns Number: 079899693

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

- Catalog Number : CORXT

Device Description : CORXTThe Peerbridge Cor™ System is a family of products comprised of two models, CORXTThe Peerbridge Cor™ System is a family of products comprised of two models, thePeerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). Thesystem is an ambulatory wearable ECG monitoring system designed to record andprovide patient's electrocardiogram (ECG) data to the clinician.The Peerbridge System consists of five components: (1) Wearable ECG Sensor withBluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld TransmitterDevice, (4) Data Upload Fixture and Software that allow ECG data to be uploaded fromthe Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-basedBackend Data Management Module. The Wearable ECG sensor attaches to the patient'schest and records the patient's ECG continuously. This device can collect two (2)channels and 3-leads of ECG data continuously for up to seven (7) days. In addition,patients can report symptomatic events by pressing the Event Button on the WearableECG Sensor or by using the mobile application on the Handheld Transmitter when asymptom is experienced. The device generates ECG reports to be displayed on theclinician's interface.The Peerbridge System Cor XT is configured for the following:- 24 hours of Holter monitoring and- Up to 7 days of Holter Monitoring

Device Class : 2

Duns Number: 079899693

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1