FDA.reportPublic FDA data

PHILIPS HeartStart Configure

Primary DI
00884838041547
Brand
PHILIPS HeartStart Configure
Company
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Model
HeartStart Configure
Catalog number
861487
Device description
HeartStart Configure
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LDDDc-Defibrillator, Low-Energy, (Including Paddles)
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111693000PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical Systems2011-10-28MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838041547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838041547008848380415478848380415470884838041547

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac output unit application softwareAn application software program designed for use in, or together with a cardiac output unit, so that this may function according to its intended purpose. This software program may be permanently installed or exchanged as an upgrade.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079503890
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838055681HeartStartFR3 Infant Child Key9898031500312014-09-24
00884838055704HeartStartFR3 System Case, Ridge9898031499712014-09-24
00884838049987PHILIPS HeartStart FR3HeartStart FR38613882014-09-24
00884838049994PHILIPS HeartStart FR3HeartStart FR38613892014-09-24
10884838002842HeartStart Adult/Child Plus PadsHeartstart PadsM3713A2022-01-06
10884838002859HeartStartHeartstart PadsM3716A2022-02-25
10884838022048Adult/Child Pre-Connect Defib PadHeartstart Pads9898031660212022-01-06
00884838111486HeartStartHeartstart PadsM3716A2022-04-08
00884838023727PHILIPS FR/FR2/FR2+ Adult Electrode PadsDP Electrode Pads9898031582212019-05-03
00884838023703PHILIPS HeartStart SMARTPADS IIFRx Smart Pads II9898031392612014-09-24
00884838023710FR2/FR2+ Adult Electrode PadsDP Electrode Pads9898031582112014-09-24
00884838023741PHILIPS HeartStart Adult SMART PadsHeartstart Adult Smart Pads CartridgeM5071A2014-09-24
00884838023765PHILIPS HeartStart SMARTPADS IIISmart Pads III9898031499812014-09-24
00884838023772PHILIPS HeartStart SMARTPADS IIISmart Pads III9898031499912014-09-24
00884838029569PHILIPS FR/FR2/FR2+ Adult Electrode Pads9898031582219898031582212014-09-24
00884838127784PHILIPS HeartStart Infant/Child SMART PadsHeartstart Infant Child Smart Pads Cart.M5072A2025-04-29
00884838023758PHILIPS HeartStart Infant/Child SMART PadsHeartstart Infant Child Smart Pads Cart.M5072A2014-09-24
00884838038004HeartStartFRx Infant Child Key9898031393112014-09-24
00884838048607HeartStartFR3 FAA Compliant Battery9898031501712018-04-20
00884838035096HeartStartFR3 Secondary Rechargeable Battery9898031502412018-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198843006614ZENIXZoll Medical CorporationMKJ2026-07-21
00198843006621ZENIXZoll Medical CorporationMKJ2026-07-21
00198843006638ZENIXZoll Medical CorporationMKJ2026-07-21
00198843006645ZENIXZoll Medical CorporationMKJ2026-07-21
00815098021475Defibtech ARM XR Extended Suction Cup (package of 1)DEFIBTECH, L.L.C.MKJ2026-06-26
00817392026248UnipowerUNIPOWER CORPORATIONLDD2026-06-02
00817392026255UnipowerUNIPOWER CORPORATIONLDD2026-06-02
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
00883873031902LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031933LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031957LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031971LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031995LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873032015LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873032145LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
10847946016231ONESTEPZoll Medical CorporationMKJ2026-02-12
10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
07613327673197LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673227LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673234LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673241LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673258LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673265LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673357LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327681864LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
00883873760482BATTERY, LI-ION, WITH IFU, LP35PHYSIO-CONTROL, INC.MKJ2025-09-26
00883873761533LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761540LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04