Zensor+ software

GUDID 05060484630051

The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The

INTELESENS LIMITED

Electrocardiography telemetric monitoring system

• Primary Device ID: 05060484630051
• NIH Device Record Key: 0a4d1f5e-1563-4583-b41f-1f913d79503f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zensor+ software
• Version Model Number: PN0811
• Company DUNS: 231959888
• Company Name: INTELESENS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060484630051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151027

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-15

Devices Manufactured by INTELESENS LIMITED

• 15060484630089 - ZENSOR: 2019-02-07 The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system con
• 05060484630099 - Zensor electrode: 2019-01-21 The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three
• 15060484630003 - ZENSOR: 2018-07-06 The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system con
• 05060484630044 - Zensoronline software: 2018-07-06 The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens'
• 05060484630051 - Zensor+ software: 2018-07-06The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The
• 05060484630051 - Zensor+ software: 2018-07-06 The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens'
• 15060484630010 - Zensor electrode: 2018-06-14 The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three
• 05060484630020 - Aingeal: 2018-03-29 The Intelesens Aingeal is used to monitor and transmit physiological data to a remote application for display or analysis by a c
• 25060484630031 - Aingeal 3-patch electrode: 2018-03-29 The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration and temperature electrode. It is a disposable, p