Resting ECG Electrodes for 12-lead

Resting ECG Electrodes for 12
N/A - 2009101-003

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 Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DRX

Device Name: Electrode, Electrocardiograph

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2360

Third Party Flag: N

Medical Specialty: CV

Device Id: 50885403252523

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 70885403252527

Package Quantity: 10

Package Discontinue Date: 3/31/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 70885403252527

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 10885403252525

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A