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Device Explorer · FDA GUDID · GMDN 48047

Non-rechargeable public automated external defibrillator

A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it automatically activates defibrillation of the heart through

US‑registered devices73in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Zoll Medical Corporation4055%
Cardiac Science Corporation1115%
Defibtech, L.L.C.1014%
Heartsine Technologies Ltd710%
Physio-Control, Inc.57%

Top labelers

CompanyDevicesShare
Zoll Medical Corporation4055%
Cardiac Science Corporation1115%
Defibtech, L.L.C.1014%
Heartsine Technologies Ltd710%
Physio-Control, Inc.57%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HeartSine Samaritan PAD 360PLIFEPAK CR2LIFEPAKAED 3ZOLL AED 3AED PLUSLifeline VIEW 2 AutoDDU-120 Lifeline AED with RX activation formLifeline VIEW AUTOLifeline AutoPowerheart® AED G3 Plus Automatic AEDPowerheart® AED G3 Plus Automatic AED, stocking Powerheart® AED G3 Automatic AEDPowerheart® G3 Elite Automatic AEDPowerheart® G5 Automatic AEDPowerheart G3 Elite Automatic AED Kit

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MKJAutomated External Defibrillators (Non-Wearable)70
MKJAutomated external defibrillators (non-wearable)24

GMDN & GCC registration

  • GMDN code 48047 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 75% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many non-rechargeable public automated external defibrillator products are registered in the US?

73 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-rechargeable public automated external defibrillator", from 5 companies. The largest labeler is Zoll Medical Corporation with 55% of records.

Which FDA product codes apply?

MKJ (Automated External Defibrillators (Non-Wearable)), MKJ (Automated external defibrillators (non-wearable))

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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