Pads, DDU-2XXX series, Adult Rescue 1 pair

GUDID 10815098020444

DEFIBTECH, L.L.C.

External defibrillation electrode, adult, single-use
Primary Device ID10815098020444
NIH Device Record Keyfa48556d-2abe-4719-b037-fc9740d11e95
Commercial Distribution StatusIn Commercial Distribution
Brand NamePads, DDU-2XXX series, Adult Rescue 1 pair
Version Model NumberDDP-2001
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
GS110815098020444 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-17
Device Publish Date2025-07-09

Devices Manufactured by DEFIBTECH, L.L.C.

10815098020420 - Pads, DDU-1XX series, Adult Rescue, 1 pair2025-07-17
10815098020444 - Pads, DDU-2XXX series, Adult Rescue 1 pair2025-07-17
10815098020444 - Pads, DDU-2XXX series, Adult Rescue 1 pair2025-07-17
10815098020017 - Lifeforce Configuration2025-07-10
10815098020055 - Lifeforce Auto Configuration2025-07-10
10815098020406 - DDU-1XXX/2XXX Series Rechargeable Battery Pack Configuration2025-07-10
10815098020819 - Defibtech ARM XR Compression Module Configuration2025-04-02
10815098020024 - ReviveR Configuration2025-03-26
10815098020062 - ReviveR Auto Configuration2025-03-26
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