Duns Number:079899693
Device Description: COREVENTThe Peerbridge Cor™ System is a family of products comprised of two models, thePee 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
Catalog Number
COREVENT
Brand Name
Peerbridge Cor System
Version/Model Number
COREVENT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171936,K171936
Product Code
DSH
Product Code Name
Recorder, Magnetic Tape, Medical
Public Device Record Key
b51899e2-e359-490f-bd1e-8a4d02d38eac
Public Version Date
July 04, 2022
Public Version Number
8
DI Record Publish Date
February 06, 2018
Package DI Number
B608COREVENT1
Quantity per Package
5
Contains DI Package
B608COREVENT0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |