DDU-1XXX/2XXX Rechargeable Battery Pack

GUDID 00815098020409

DEFIBTECH, L.L.C.

Secondary battery Secondary battery
Primary Device ID00815098020409
NIH Device Record Key3fe20590-7d01-43f6-b994-2dd4b36c8cdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-1XXX/2XXX Rechargeable Battery Pack
Version Model NumberDBP-2009
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 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
GS100815098020409 [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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