PHILIPS HeartStart FRx 861338

GUDID 00884838050709

Guidelines Update, New FRx

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
Primary Device ID00884838050709
NIH Device Record Keyad7a139a-77ac-4eee-ae20-de4624b410ed
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHILIPS HeartStart FRx
Version Model Number861338
Catalog Number861338
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 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
GS100884838050709 [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

On-Brand Devices [PHILIPS HeartStart FRx]

00884838080768861304
00884838050716Guidelines Update, FRx
00884838050709Guidelines Update, New FRx
00884838006560HeartStart FRx Defibrillator
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