PHILIPS HeartStart FR3 with ECG and Soft Case 860362

GUDID 00884838051423

FR3 ECG, US English, Soft System Bundle

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator
Primary Device ID00884838051423
NIH Device Record Key2f81bed3-b747-4b17-9892-45b3209ce99f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHILIPS HeartStart FR3 with ECG and Soft Case
Version Model Number860362
Catalog Number860362
Company DUNS079503890
Company NamePHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS100884838051423 [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 Date2014-09-24

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