Zensor electrode

Primary DI
05060484630099
Brand
Zensor electrode
Company
INTELESENS LIMITED
Model
PN1360
Device description
The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three lead electrode array, which is in contact with the patient's skin. The device is used in conjunction with the zensor device in order to monitor vital signs for ECG, respiration and motion for ambulatory and non-ambulatory patients in a home environment. This is a single use device and is intended to be used on an adult patient for a period of up to 6 days before a replacement is required.
Published
2018-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060484630099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060484630099050604846300995060484630099

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.

Sterilization Methods#

Method table
Method

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
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
05060484630037Aingeal 3-patch electrodePN11202017-02-01
05060484630020AingealPN11112017-08-31
25060484630031Aingeal 3-patch electrodePN11202017-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00326053105456Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105463Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105470Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
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