Peerbridge Cor System

Primary DI
B608COREVENT0
Brand
Peerbridge Cor System
Company
PEERBRIDGE HEALTH, INC.
Model
COREVENT
Catalog number
COREVENT
Device description
"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"
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSHRecorder, Magnetic Tape, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171936000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171936000Peerbridge Cor(TM) SystemPeerbridge Health, Inc.2017-09-27DSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B608COREVENT1PackageHIBCC5In Commercial Distribution
B608COREVENT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Photoplethysmography/accelerometery recording sensorAn electrically-powered, wearable device (e.g., wristband, finger probe, head-worn sensor) designed to continuously measure and record: 1) photoplethysmography (PPG) data (e.g., pertaining to heart rate, respiration rate); and, 2) movement, during normal day- and/or night-time activities at home. It includes an optical PPG sensor and an accelerometer. The data is typically transferred to a local application or central database for analysis which includes evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7736778886c.pillar@peerbridgehealth.com

Regulatory Flags#

DUNS number
079899693
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B608CORXT0Peerbridge Cor SystemCORXTCORXT2018-02-12
B608CORXT1Peerbridge Cor SystemCORXTCORXT2018-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-05-18
00857522005125myPatch®DMS-SERVICE LLCDSH2026-05-06
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
K00010eWave 6-Lead EKGWearlinq, Inc.DSH2026-04-02
P00010eWave Electrode PatchWearlinq, Inc.DSH2026-04-02
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
17540279200027CardioSTATIcentia Inc.DSH2025-12-08
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
08800069700260AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
27540279250029CardioSTATIcentia Inc.DSH2024-12-18
27540279250074CardioSTATIcentia Inc.DSH2024-12-18
27540279250142CardioSTATIcentia Inc.DSH2024-12-18
00884838123717Care AssistPhilips Medical Systems HsgDSH2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgDSH2024-11-27
00860007323409Vitals360Vocare, Inc.DSH2024-09-10
B146EP25R0ePatch Sensor 2.5, RebuiltBRAEMAR MANUFACTURING, LLCDSH2024-06-26
04250413405640ABPM pro basic deviceSOMNOmedics AGDSH2024-05-08
00815187020112Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020440Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020457Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020587Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020594Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
17540279105018EARTIcentia Inc.DSH2024-03-26
17540279200072CardioSTATIcentia Inc.DSH2024-03-26