DDU-1XX Series Adult Rescue Pads

GUDID 00815098020423

DEFIBTECH, L.L.C.

External defibrillator electrode, adult, single-use
Primary Device ID00815098020423
NIH Device Record Key439139c0-127b-4c20-ad28-b8eaab5e4cd1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-1XX Series Adult Rescue Pads
Version Model NumberDDP-100
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815098020423 [Primary]
GS130815098020424 [Package]
Package: [10 Units]
In Commercial Distribution
GS150815098020428 [Package]
Contains: 30815098020424
Package: [4 Units]
In Commercial Distribution

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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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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