PHILIPS HeartStart Configure 861487

GUDID 00884838041547

HeartStart Configure Software

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Cardiac output unit application software
Primary Device ID00884838041547
NIH Device Record Key6ea6c893-34b2-43f7-b8b8-fe51a4a37ba3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHILIPS HeartStart Configure
Version Model Number861487
Catalog Number861487
Company DUNS079503890
Company NamePHILIPS ELECTRONICS NORTH AMERICA CORPORATION
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838041547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDDDc-Defibrillator, Low-Energy, (Including Paddles)

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 Date2014-09-24

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