FDA.reportPublic FDA data

HeartStart

Primary DI
00884838106635
Brand
HeartStart
Company
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Model
989803210531
Catalog number
989803210531
Published
2021-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDDDc-defibrillator, low-energy, (including paddles)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838106635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838106635008848381066358848381066350884838106635

GMDN Terms#

Term, Definition table
TermDefinition
Internal defibrillator electrode, adultAn electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop/start the heartbeat during cardiopulmonary surgery. It usually consists of a cable set with spoon-like electrodes (commonly known as internal defibrillator paddles or spoons) that are held by the operator directly to either side of the heart muscle so that the discharge passes directly through the heart. It is typically available as a set of two electrodes with insulated handles with a combined cable/connector. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
079503890
Device count
1
Serial number
true
Sterilization required before use
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817392026248UnipowerUNIPOWER CORPORATIONLDD2026-06-02
00817392026255UnipowerUNIPOWER CORPORATIONLDD2026-06-02
00817392026217UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392026224UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392026231UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392025647UnipowerUNIPOWER CORPORATIONLDD2024-02-13
00817392025654UnipowerUNIPOWER CORPORATIONLDD2024-02-13
00817392025593UnipowerUNIPOWER CORPORATIONLDD2024-01-10
00817392025609UnipowerUNIPOWER CORPORATIONLDD2024-01-10
00817392025616UnipowerUNIPOWER CORPORATIONLDD2024-01-10
10888277634930MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634954MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634947MedlineMEDLINE INDUSTRIES, INC.LDD2021-09-16
00817392025289UnipowerUNIPOWER CORPORATIONLDD2021-04-30
07613365002737Tempus LS-MANUALSchiller AGLDD2020-08-11
08054242441765NAFIAB SPALDD2020-04-12
08054242441772NAFIAB SPALDD2020-04-12
08054242441789NAFIAB SPALDD2020-04-12
08054242441796NAFIAB SPALDD2020-04-12
08054242441802NAFIAB SPALDD2020-04-12
08054242441819NAFIAB SPALDD2020-04-12
08054242441826NAFIAB SPALDD2020-04-12
08054242441833NAFIAB SPALDD2020-04-12
08054242441840NAFIAB SPALDD2020-04-12
08054242441857NAFIAB SPALDD2020-04-12
08054242441871NAFIAB SPALDD2020-04-12
08054242441895NAFIAB SPALDD2020-04-12
08054242444933NAFIAB SPALDD2020-04-12
08054242446425NAFIAB SPALDD2020-04-12
08054242446432NAFIAB SPALDD2020-04-12