DDU-1XX Series Adult Pads Adapters, Physio-Control

GUDID 00815098020478

DEFIBTECH, L.L.C.

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable
Primary Device ID00815098020478
NIH Device Record Key5210c1b2-66dd-41bf-9d25-b9ed03de4d48
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-1XX Series Adult Pads Adapters, Physio-Control
Version Model NumberDAC-300E
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100815098020478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

Devices Manufactured by DEFIBTECH, L.L.C.

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00815098020737 - DDU-100 Lifeline AED with RX activation form2021-08-09 DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year batte
00815098020744 - DDU-100 Lifeline AED with RX activation form2021-08-09 DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 7 year batte
00815098020751 - DDU-120 Lifeline AED with RX activation form2021-08-09 DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year
00815098020768 - DDU-120 Lifeline AED with RX activation form2021-08-09 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
00815098020775 - DDU-2300 Lifeline VIEW with RX activation form2021-08-09 DDU-2300 Lifeline VIEW, US, English, 1 set Adult Pads (DDP-2001), Quick Start Card (DAC-2501), Op. Guide (DAC-A2530EN), 4 year b
00815098020782 - DDU-2450 Lifeline ECG with RX activation form2021-08-09 DDU-2450 Lifeline ECG, US, English, 1 set Adult Pads (DDP-2001), Quick Start Card (DAC-2501), Op. Guide (DAC-A2530EN), 4 year ba

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