FDA.reportPublic FDA data

PHILIPS HeartStart OnSite

Primary DI
00884838050693
Brand
PHILIPS HeartStart OnSite
Company
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Model
861337
Catalog number
861337
Device description
Guidelines Update, Home
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
NSAOver-The-Counter Automated External Defibrillator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSAOver-The-Counter Automated External DefibrillatorCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040904000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040904000PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068APhilips Medical Systems2004-09-16NSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838050693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838050693008848380506938848380506930884838050693

GMDN Terms#

Term, Definition table
TermDefinition
Home automated external defibrillatorA portable electronic device intended for use at home to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It is designed to be used by a layperson and consists of an external pulse generator (EPG) and skin-adhesive electrodes that monitor the rhythm/deliver the shocks; it includes a non-rechargeable battery for energy that requires replacement when indicated by the EPG. It may be available [non-prescription] over-the-counter (OTC).

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
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
00884838076716PHILIPS HeartStart HOMEPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONNSA2016-05-12
00884838075849HeartStart PHILIPS ELECTRONICS NORTH AMERICA CORPORATIONNSA2016-04-14
00884838023741PHILIPS HeartStart Adult SMART PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONNSA2014-09-24
00884838049130PHILIPS HeartStart HOMEPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONNSA2014-09-24