DDU-100 Lifeline AED with RX activation form

GUDID 00815098020744

DDU-100 Lifeline 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 semi-automated external defibrillator
Primary Device ID00815098020744
NIH Device Record Keye6c34096-354f-4d2c-a259-e47e729e70dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-100 Lifeline AED with RX activation form
Version Model NumberDCF-A110RX-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
GS100815098020744 [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 activation form]

00815098020744DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. G
00815098020737DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. G

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