DEVICE: Aingeal 3-patch electrode (05060484630037)

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Device Identifier (DI) Information

Aingeal 3-patch electrode
PN1120

INTELESENS LIMITED
05060484630037
GS1
1
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.
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Device Characteristics

MR Unsafe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrocardiographic electrode, single-use A non-sterile electrical conductor designed to transmit cardiac bioelectric signals (typically from the thoracic surface) to devices that record and/or process the signals (e.g., electrocardiographs, vectorcardiographs, electrocardiographic monitors). 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., 12) connected to appropriate leads and cables. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MLN Electrode, Electrodcardiograph, Multi-Function
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
February 01, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
25060484630031 25 15060484630034 In Commercial Distribution Box
15060484630034 4 05060484630037 In Commercial Distribution Foil pouch
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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