DDU-120 Lifeline AED with RX activation form

GUDID 00815098020768

DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 7 year battery pack with 9V Lithium battery (DCF-210), prescription activation form

DEFIBTECH, L.L.C.

Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator
Primary Device ID00815098020768
NIH Device Record Keyd0a69fb0-bad3-46dd-a355-b819f5b7d89c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-120 Lifeline AED with RX activation form
Version Model NumberDCF-A130RX-EN
Company DUNS128340200
Company NameDEFIBTECH, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815098020768 [Primary]

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-09
Device Publish Date2021-07-30

On-Brand Devices [DDU-120 Lifeline AED with RX activation form]

00815098020768DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501),
00815098020751DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501),

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.