Aingeal

GUDID 05060484630020

The Intelesens Aingeal is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device

INTELESENS LIMITED

Electrocardiography telemetric monitoring system

• Primary Device ID: 05060484630020
• NIH Device Record Key: ab47a18a-6283-47ad-a4b2-158cf66c9314
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aingeal
• Version Model Number: PN1111
• 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: false
• Serial Number: true
• 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	05060484630020 [Direct Marking]
GS1	15060484630027 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-31

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: 2018-07-06 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: 2018-03-29The Intelesens Aingeal is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device
• 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