DDU-1XXX/2XXX Series Pediatric Pads Configuration

GUDID 10815098020451

DEFIBTECH, L.L.C.

External defibrillation electrode, paediatric, single-use
Primary Device ID10815098020451
NIH Device Record Keyaff4f326-76a7-4f21-b97d-dd43c82de0db
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-1XXX/2XXX Series Pediatric Pads Configuration
Version Model NumberDDP-2002
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
GS110815098020451 [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 Number5
Public Version Date2023-07-06
Device Publish Date2015-10-24

Devices Manufactured by DEFIBTECH, L.L.C.

10815098020475 - DDU-1XX Series Adult Pads Adapter, Physio-Control Configuration2024-06-06
10815098020482 - DDU-1XX Series Adult Pads Adapter, Zoll Configuration2024-06-06
10815098020499 - DDU-1XXX/2XXX Adult Pads Adapter, Physio-Control Configuration2024-06-06
10815098020505 - DDU-1XXX/2XXX Adult Pads Adapter, Zoll Configuration2024-06-06
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
10815098020451 - DDU-1XXX/2XXX Series Pediatric Pads Configuration2023-07-06

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