FDA device listing
DBP-1400 5-year non-rechargeable battery pack,DBP-2003 4-year non-rechargeable battery pack,DBP-2013 4-year…
FDA device listing 1778325734 · DEFIBTECH, LLC
Key facts
| Proprietary names | DBP-1400 5-year non-rechargeable battery pack,DBP-2003 4-year non-rechargeable battery pack,DBP-2013 4-year non-rechargeable TSO battery,DBP-2800 7-year non-rechargeable battery pack,DDP-100 Adult Defibrillation Pads,DDP-2001 Adult Defibrillation Pads,DDP-2002 Pediatric Defibrillation Pads,DDP-200P Pediatric Defibrillation Pads,Lifeline Auto DDU-120 Fully-Automatic AED,Lifeline DDU-100… |
|---|---|
| Owner/operator | DEFIBTECH, LLC |
| Owner/operator number | 9048526 |
| Premarket submissions | P160032 |
| Product codes | MKJ |
| Device names | MKJ - Automated External Defibrillators (Non-Wearable) |
| Device class | Class III |
| Classification regulations (21 CFR) | 870.5310 |
| Review panels | Cardiovascular |
| Registered establishments | Defibtech Branford, DEFIBTECH LLC, DEFIBTECH, LLC |
| Establishment registrations | 3003521780, 3012972516, 3026976873 |
| FEI numbers | 3003521780, 3012972516, 3026976873 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database