DDU-2450 Lifeline ECG with RX activation form

GUDID 00815098020782

DDU-2450 Lifeline ECG, US, English, 1 set Adult Pads (DDP-2001), Quick Start Card (DAC-2501), Op. Guide (DAC-A2530EN), 4 year battery pack (DCF-2003), prescription activation form

DEFIBTECH, L.L.C.

Non-rechargeable professional semi-automated external defibrillator
Primary Device ID00815098020782
NIH Device Record Key8d18dc4b-65ea-45b5-b3e1-82c47623c2d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-2450 Lifeline ECG with RX activation form
Version Model NumberDCF-A2460RX
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
GS100815098020782 [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

Devices Manufactured by DEFIBTECH, L.L.C.

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10815098020512 - DDU-2XXX Series ECGMA Cable, AAMI Configuration2024-06-06
10815098020529 - DDU-2XXX Series ECGMA Cable, IEC Configuration2024-06-06
10815098020437 - DDU-1XX Series Pediatric Pads Configuration2023-07-06
10815098020451 - DDU-1XXX/2XXX Series Pediatric Pads Configuration2023-07-06

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