Aingeal

Primary DI
15060484630027
Brand
Aingeal
Company
INTELESENS LIMITED
Model
PN1111
Device description
The Intelesens Aingeal is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.This re-usable device is intend to be used on the patient for short term periods only.The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia event (arrhythmia or threshold breach).
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060484630020Direct MarkingGS10
15060484630027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060484630020050604846300205060484630020
1506048463002715060484630027

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Regulatory Flags#

DUNS number
231959888
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060484630082ZENSORPN12872019-01-07
15060484630089ZENSORPN12872019-01-07
05060484630099Zensor electrodePN13602018-12-21
05060484630006ZENSORPN06202018-05-14
15060484630003ZENSORPN06202018-05-14
05060484630044Zensoronline softwarePN08102018-05-15
05060484630051Zensor+ softwarePN08112018-05-15
05060484630013Zensor electrodePN10882018-05-14
15060484630010Zensor electrodePN10882018-05-14
05060484630037Aingeal 3-patch electrodePN11202017-02-01
05060484630020AingealPN11112017-08-31
25060484630031Aingeal 3-patch electrodePN11202017-02-01

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