FDA.reportPublic FDA data

PHILIPS HeartStart FR2+

Primary DI
00884838050730
Brand
PHILIPS HeartStart FR2+
Company
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Model
861365
Catalog number
861365
Device description
Guideline 2005 Exch, FR2+ Text, Philips
Published
2014-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051632000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051632000PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841APhilips Medical Systems2005-10-05MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838050730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838050730008848380507308848380507300884838050730

GMDN Terms#

Term, Definition table
TermDefinition
Non-rechargeable public automated external defibrillatorA portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it automatically activates defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes a non-rechargeable battery for energy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079503890
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838126510HeartStart Adult/Child Plus PadsHeartstart PadsM3713A2026-08-10
00884838126527HeartStartHeartstart PadsM3716A2026-08-10
00884838126534HeartStart Adult/Child Plus PadsHeartstart PadsM3717A2026-08-10
00884838126541Adult/Child Pre-Connect Defib PadHeartstart Pads9898031660212026-08-10
00884838023727PHILIPS FR/FR2/FR2+ Adult Electrode PadsDP Electrode Pads9898031582212019-05-03
00884838023710FR2/FR2+ Adult Electrode PadsDP Electrode Pads9898031582112014-09-24
00884838126275PHILIPS HeartStart SMARTPADS IIFRx Smart Pads II9898031392612026-08-26
00884838126282PHILIPS HeartStart SMARTPADS IIISmart Pads III9898031499812026-08-26
00884838126299FR2/FR2+ Adult Electrode PadsDP Electrode Pads9898031582112026-08-26
00884838126473PHILIPS HeartStart SMARTPADS IIISmart Pads III9898031499912026-08-26
00884838126480PHILIPS FR/FR2/FR2+ Adult Electrode PadsDP Electrode Pads9898031582212026-08-26
00884838023703PHILIPS HeartStart SMARTPADS IIFRx Smart Pads II9898031392612014-09-24
00884838023765PHILIPS HeartStart SMARTPADS IIISmart Pads III9898031499812014-09-24
00884838023772PHILIPS HeartStart SMARTPADS IIISmart Pads III9898031499912014-09-24
10884838002842HeartStart Adult/Child Plus PadsHeartstart PadsM3713A2022-01-06
10884838002866HeartStartHeartstart PadsM3717A2022-01-06
10884838022048Adult/Child Pre-Connect Defib PadHeartstart Pads9898031660212022-01-06
00884838111486HeartStartHeartstart PadsM3716A2022-04-08
00884838055681HeartStartFR3 Infant Child Key9898031500312014-09-24
00884838055704HeartStartFR3 System Case, Ridge9898031499712014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00847946050740ZENIXZoll Medical CorporationMKJ2026-09-25
00847946030926ZENIXZoll Medical CorporationMKJ2026-08-26
00884838126275PHILIPS HeartStart SMARTPADS IIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126282PHILIPS HeartStart SMARTPADS IIIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126299FR2/FR2+ Adult Electrode PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126473PHILIPS HeartStart SMARTPADS IIIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126480PHILIPS FR/FR2/FR2+ Adult Electrode PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
10847946030954ZENIXZoll Medical CorporationMKJ2026-08-14
00884838126510HeartStart Adult/Child Plus PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-10
00884838126527HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-10
00884838126534HeartStart Adult/Child Plus PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-10
00884838126541Adult/Child Pre-Connect Defib PadPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-10
00198843006614ZENIXZoll Medical CorporationMKJ2026-07-21
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