FDA.reportPublic FDA data

PHILIPS HeartStart HOME

Primary DI
00884838076716
Brand
PHILIPS HeartStart HOME
Company
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Model
861284
Catalog number
861284
Published
2016-05-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

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
00884838076716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838076716008848380767168848380767160884838076716

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
079503890
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838023710FR2/FR2+ Adult Electrode PadsDP Electrode Pads9898031582112014-09-24
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
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
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
00884838050693PHILIPS HeartStart OnSitePHILIPS ELECTRONICS NORTH AMERICA CORPORATIONNSA2014-09-24