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pma Primary ID: P180028

HeartStart FRx Defibrillator and HeartStart SMART Pads II (UDI P180028)

Manufactured by Philips Medical Systems

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HeartStart FRx Defibrillator and HeartStart SMART Pads II - Primary ID P180028

Device Regulatory Overview

The HeartStart FRx Defibrillator and HeartStart SMART Pads II (Model/Catalog Number: Unspecified) is a medical device manufactured by Philips Medical Systems. This product is indexed under FDA Product Code / Category Classification MKJ within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0745-2016 View Full Alert →

DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-0010-2017 View Full Alert →

Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-0012-2017 View Full Alert →

Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
N/A
Product Code / EMDN
MKJ
Device Name
Automated external defibrillators (non-wearable)
Database Sync Date
2026-08-09 10:06:23

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of HeartStart FRx Defibrillator and HeartStart SMART Pads II?

The registered manufacturer of record for HeartStart FRx Defibrillator and HeartStart SMART Pads II is Philips Medical Systems.

What is the Primary UDI-DI identifier for HeartStart FRx Defibrillator and HeartStart SMART Pads II?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P180028.

What classification code is assigned to this device?

This device is registered under product classification code MKJ.

Similar Classification Devices (MKJ)

Other Devices by Philips Medical Systems

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