Peerbridge Cor System

Basic Information

• Brand Name: Peerbridge Cor System
• Primary DI: B608COREVENT0
• Version / Model: COREVENT
• Catalog Number: COREVENT
• Company Name: PEERBRIDGE HEALTH, INC.
• Labeler DUNS: 079899693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-06
• Public Version: 8
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: b51899e2-e359-490f-bd1e-8a4d02d38eac

Device 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

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12391	Wearable multiple physiological parameter recorder, reusable	An electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B608COREVENT0	HIBCC
Package	B608COREVENT1	HIBCC	Box	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171936	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 32 – 140 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit