DDU-1XXX/2XXX Series Battery Pack

GUDID 00815098020393

DEFIBTECH, L.L.C.

Primary battery
Primary Device ID00815098020393
NIH Device Record Keyac6462b2-c78a-4a9e-b7ba-07cda5fe8ba2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-1XXX/2XXX Series Battery Pack
Version Model NumberDBP-2003
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
GS100815098020393 [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

On-Brand Devices [DDU-1XXX/2XXX Series Battery Pack]

00815098020416DBP-2013
00815098020393DBP-2003

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