Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-
FDA premarket approval P160032 · Automated external defibrillators (non-wearable)
Approval
- Applicant
- Defibtech, LLC
- Received
- August 2, 2016
- Decision date
- February 1, 2018 (APPR)
- Supplements
- 17, latest August 25, 2026
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
Approval order statement
Approval of the Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-2200, Lifeline/ReviveR ECG DDU-2450, and Lifeline/ReviveR ECG+ DDU-2475 Automated External Defibrillators.The Lifeline/ReviveR DDU-100 series Automated External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:1) Unconscious and unresponsive; and2) Not breathing or not breathing normally.Lifeline/ReviveR DDU-100 series AEDs may be used with Defibtech adult defibrillation pads (model number DDP-100). For patients under 8 years old, or weighing less than 55 lbs (25 kg), use Defibtech child/infant defibrillation pads (model number DDP-200P), if available.The Lifeline/ReviveR DDU-2000 series Automated External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:1) Unconscious and unresponsive; and2) Not breathing or not breathing normally.Lifeline/ReviveR DDU-2000 series AEDs may be used with Defibtech adult defibrillation pads (model number DDP-2001). For patients under 8 years old, or weighing less than 55 lbs (25 kg), use Defibtech child/infant defibrillation pads (model number DDP-2002), if available.