![]() from manufacturing through distribution to patient use. The Global Unique Device Identification Database (GUDID) lists most medical devices legally sold in the U.S. Locate the unique device identifier (UDI) on the AED or AED accessory product labels before you purchase them and consider searching the UDI in the AccessGUDID Database.Select and purchase necessary AED accessories directly from authorized retailers to help ensure that you are purchasing an FDA-approved device.They are not FDA-approved and you have not received a letter from the manufacturer.You are not sure if your AED or AED accessories are FDA-approved or.Contact the manufacturer of your AED or necessary AED accessories if:.Check the tables below to see if your AED system and AED accessories are FDA-approved.If you or your organization owns an AED system, the FDA recommends you: There are FDA-approved AEDs and AED accessories available, and we encourage you to ensure your AED and AED accessories are FDA-approved if they are not, we encourage you to transition to FDA-approved AEDs and AED accessories. Fully automated defibrillators analyze the heart's rhythm and deliver a defibrillation shock if commanded by the device software without user intervention.Ĭheck Your AED and AED Accessories: Are They FDA Approved?.Semi-automated defibrillators analyze the heart's rhythm, and if an abnormal heart rhythm is detected that requires a shock, then the device prompts the user to press a button to deliver a defibrillation shock.Professional use AEDs are used by first responders, such as emergency medical technicians (EMTs) and paramedics, who receive additional AED training.ĪEDs can be semi-automated or fully automated.They are intended to be used by laypeople who have received minimal training. ![]() Public access AEDs can be found in airports, community centers, schools, government buildings, hospitals, and other public locations.There are two main types of AEDs: public access and professional use. The AED system includes accessories, such as a battery and pad electrodes, that are necessary for the AED to detect and interpret a person's heart rhythm and deliver an electrical shock if one is needed. ![]() When appropriate, it delivers an electrical shock to the heart to restore its normal rhythm. AEDs are a type of computerized defibrillator that automatically analyzes the heart rhythm in people who are experiencing cardiac arrest. ![]()
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