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Peerbridge Cor System

FDA UDI

Class II (US FDA UDI)

by Peerbridge Health, Inc.

Identity

Trade Name
Peerbridge Cor System FDA UDI
Generic Name
Wearable multiple physiological parameter recorder, reusable FDA UDI
Device Name
COREVENT The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient's electrocardiogram (ECG) data to the clinician. The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient's chest 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 Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician's interface. The Peerbridge System Cor Event is configured for the following: - 24 hours of Holter monitoring - Patient Activated Event with Surveillance FDA UDI
Model / Reference
COREVENT FDA UDI
Description
COREVENT The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient's electrocardiogram (ECG) data to the clinician. The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient's chest 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 Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician's interface. The Peerbridge System Cor Event is configured for the following: - 24 hours of Holter monitoring - Patient Activated Event with Surveillance FDA UDI

Identifiers

Catalog Number
COREVENT FDA UDI
Primary DI / UDI-DI
B608COREVENT0 FDA UDI
510(k) Number
K171936 FDA UDI
FDA Product Code
DSH FDA UDI
GMDN Term
Wearable multiple physiological parameter recorder, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Wearable multiple physiological parameter recorder, reusable

Peerbridge Cor System by Peerbridge Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable multiple physiological parameter recorder, reusable.

Cleared under the same submission

K171936 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Peerbridge Health, Inc.

Sources (1)

  • FDA UDI b51899e2-e359-490f-bd1e-8a4d02d38eac 37 fields · synced Jun 8, 2026