Aingeal 3-patch electrode

Basic Information

• Brand Name: Aingeal 3-patch electrode
• Primary DI: 05060484630037
• Version / Model: PN1120
• Company Name: INTELESENS LIMITED
• Labeler DUNS: 231959888
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 15ae9471-73f7-4ad1-a443-5951eb63abd1

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MLN	Electrode, Electrodcardiograph, Multi-Function	Cardiovascular	870.2360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35035	Electrocardiographic electrode, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25060484630031	GS1	Box	25	In Commercial Distribution
Package	15060484630034	GS1	Foil pouch	4	In Commercial Distribution
Primary	05060484630037	GS1