Peerbridge Cor System

Primary DI
B608CORXT1
Brand
Peerbridge Cor System
Company
PEERBRIDGE HEALTH, INC.
Model
CORXT
Catalog number
CORXT
Device description
CORXT 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 XT is configured for the following: - 24 hours of Holter monitoring and - Up to 7 days of Holter Monitoring
Published
2018-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
B608CORXT1PackageHIBCC5In Commercial Distribution
B608CORXT0PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B608CORXT0Peerbridge Cor SystemCORXTCORXT2018-02-12
B608COREVENT0Peerbridge Cor System COREVENTCOREVENT2018-02-06

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