Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-

Automated External Defibrillators (non-wearable)

FDA Premarket Approval P160032

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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.

DeviceLifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-
Classification NameAutomated External Defibrillators (non-wearable)
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantDEFIBTECH, LLC
Date Received2016-08-02
Decision Date2018-02-01
Notice Date2018-05-14
PMAP160032
SupplementS
Product CodeMKJ
Docket Number18M-0528
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address DEFIBTECH, LLC 741 Boston Post Road suite 201 guilford, CT 06437
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P160032Original Filing
S010 2021-06-14 Real-time Process
S009 2020-07-27 Real-time Process
S008 2020-07-21 Real-time Process
S007 2020-05-26 30-day Notice
S006 2020-05-08 30-day Notice
S005
S004 2020-01-27 Real-time Process
S003
S002
S001 2018-11-09 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00815098020195 P160032 000

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