Aingeal 3-patch electrode

Primary DI
05060484630037
Brand
Aingeal 3-patch electrode
Company
INTELESENS LIMITED
Model
PN1120
Device description
The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration and temperature electrode. It is a disposable, pre-gelled, self-adhesive, single lead electrode array, which is designed to be used in contact with the patient’s skin. The device is used in conjunction with the Aingeal Device in order to monitor vital signs for ECG, respiration, motion and temperature for ambulatory and non-ambulatory patients in a hospital environment.This is a single use device and is intended to be used on an adult patient for a period of up to 72 hours before a replacement is required.
Published
2017-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MLNElectrode, Electrodcardiograph, Multi-Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLNElectrode, Electrocardiograph, Multi-FunctionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060484630034PackageGS14In Commercial Distribution
25060484630031PackageGS125In Commercial Distribution
05060484630037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506048463003415060484630034
2506048463003125060484630031
05060484630037050604846300375060484630037

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Regulatory Flags#

DUNS number
231959888
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
15060484630027AingealPN11112017-08-31
05060484630020AingealPN11112017-08-31
25060484630031Aingeal 3-patch electrodePN11202017-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00326053105456Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
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00326053105470Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
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