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
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
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
97211b0c-de32-4afc-9481-376809ba2352
Public Version Date
July 04, 2022
Public Version Number
8
DI Record Publish Date
February 12, 2018
Package DI Number
B608CORXT1
Quantity per Package
5
Contains DI Package
B608CORXT0
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 |