Vendor/Manufacturer: Medtronic
Product/Product Line: Single Chamber Temporary External Pacemaker Model 53401
Global Unique Device (GUD) Primary Device Identifier Number: 00643169723160
Global Unique Device (GUD) Device Description:
EPG 53401 MKT US
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
External pacemaker, epicardial pacing
Global Medical Device Nomenclature (GMDN) Definition:
An external pulse generator (EPG) designed to generate periodic electrical cardiac pacing impulses and transmits them to the heart via invasive (percutaneous) leads to stimulate the heart when the sino-atrial (SA) node is not functioning properly or when the heart has a conductive disorder. It is commonly used: 1) in an emergency; 2) during surgery; or 3) following open-heart surgery until the heart recovers. It is not intended for defibrillation or cardioversion. The leads (not included) are inserted into the heart through a major vein (e.g., subclavian) or attached directly to the heart wall.
FDA Regulation Medical Specialty: Cardiovascular Devices - Cardiovascular Prosthetic Devices
FDA Regulation Number: 870.3600
FDA Regulation Description Classification Name:
External pacemaker pulse generator
FDA Classification Product Code: DTE
FDA Classification Product Code Device Name:
Pulse-Generator, Pacemaker, External
The Medtronic Single Chamber Temporary External Pacemaker Model 53401 is
SUBSTANTIALLY EQUIVALENT to the following product:
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