DDU-100 Lifeline AED with RX form and cabinet

GUDID 00815098020805

DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year battery pack with 9V Lithium battery (DCF-200), alarmed wall mount cabinet (DAC-220), rescue pack (DAC-420), 3-way wall sign (DAC-230), soft carry case (DAC-100), pediatric pads (DDP-200P), prescription activation form

DEFIBTECH, L.L.C.

Non-rechargeable public semi-automated external defibrillator Non-rechargeable public semi-automated external defibrillator Non-rechargeable public semi-automated external defibrillator Non-rechargeable public semi-automated external defibrillator Non-rechargeable public semi-automated external defibrillator Non-rechargeable public semi-automated external defibrillator Non-rechargeable public semi-automated external defibrillator
Primary Device ID00815098020805
NIH Device Record Key6d6bd6b9-b481-4b65-9d70-e954683ae178
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-100 Lifeline AED with RX form and cabinet
Version Model NumberCCPRX-0003
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
GS100815098020805 [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-100 Lifeline AED with RX form and cabinet]

00815098020805DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. G
00815098020799DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. G

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