FDA.reportPublic FDA data

Adult/Child Pre-Connect Defib Pad

Primary DI
10884838022048
Brand
Adult/Child Pre-Connect Defib Pad
Company
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Model
Heartstart Pads
Catalog number
989803166021
Device description
Adult/Child Preconnect Multifunction Electrode Pads
Published
2022-01-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884838022048PrimaryGS10
00884838111332Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088483802204810884838022048
00884838111332008848381113328848381113320884838111332

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillation electrode, adult, single-useAn electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) designed to be applied to the chest or back of the patient so that the discharge passes across the region of the heart. It may also be used for electrocardiographic analysis prior to shock delivery. The device may remain applied to the patient during stages of treatment. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
079503890
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884838002842HeartStart Adult/Child Plus PadsHeartstart PadsM3713A2022-01-06
10884838002866HeartStartHeartstart PadsM3717A2022-01-06
00884838111486HeartStartHeartstart PadsM3716A2022-04-08
00884838055681HeartStartFR3 Infant Child Key9898031500312014-09-24
00884838055704HeartStartFR3 System Case, Ridge9898031499712014-09-24
00884838049987PHILIPS HeartStart FR3HeartStart FR38613882014-09-24
00884838049994PHILIPS HeartStart FR3HeartStart FR38613892014-09-24
10884838002859HeartStartHeartstart PadsM3716A2022-02-25
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

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Primary DI, Brand, Company table
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07613327673357LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327681864LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
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