PHILIPS HeartStart FR3 with Text and Rigid Case 860363

GUDID 00884838051430

FR3 Text, US English Rigid System Bundle

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Non-rechargeable public automated external defibrillator
Primary Device ID00884838051430
NIH Device Record Key19a3f6bd-9a63-4048-a847-a3156a0eb7ed
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHILIPS HeartStart FR3 with Text and Rigid Case
Version Model Number860363
Catalog Number860363
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
GS100884838051430 [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

Devices Manufactured by PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

00884838123939 - HeartStart2024-10-14 FRx Aviation Battery Pack
00884838124196 - HeartStart2024-10-07 Primary Battery
00884838123922 - HeartStart2024-09-02 Primary Battery
00884838111325 - HeartStart Adult/Child Plus Pads2023-07-06 HeartStart Adult/Child Plus Pads
00884838055728 - HeartStart2023-04-14 CPR Compression Meter Adhesive Pads 10-Set
00884838111349 - HeartStart Adult/Child Plus Pads2022-08-04 HeartStart Infant Plus Pads
00884838111332 - Adult/Child Pre-Connect Defib Pad2022-08-04 Adult/Child Pre-Connect Defib Pad
00884838111493 - HeartStart2022-03-07 HS Adult/Child Radiolucent Pads

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.