Peerbridge Cor System - CORXTThe Peerbridge Cor™ System is a family of - PEERBRIDGE HEALTH, INC.

Duns Number:079899693

Device Description: CORXTThe Peerbridge Cor™ System is a family of products comprised of two models, thePeerbr 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

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More Product Details

Catalog Number

CORXT

Brand Name

Peerbridge Cor System

Version/Model Number

CORXT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

DSH

Product Code Name

Recorder, Magnetic Tape, Medical

Device Record Status

Public Device Record Key

97211b0c-de32-4afc-9481-376809ba2352

Public Version Date

July 04, 2022

Public Version Number

8

DI Record Publish Date

February 12, 2018

Additional Identifiers

Package DI Number

B608CORXT1

Quantity per Package

5

Contains DI Package

B608CORXT0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"PEERBRIDGE HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1