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Device Explorer · FDA GUDID · GMDN 47910

Non-rechargeable public semi-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 audibly/visually instructs an operator to enable it to activ

US‑registered devices225in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Zoll Medical Corporation16975%
Cardiac Science Corporation178%
Defibtech, L.L.C.157%
Heartsine Technologies Ltd146%
Physio-Control, Inc.63%
Philips Electronics North America Corporation21%
Avalign Technologies, Inc.10%
Cu Medical Systems, Inc.10%

Top labelers

CompanyDevicesShare
Zoll Medical Corporation16975%
Cardiac Science Corporation178%
Defibtech, L.L.C.157%
Heartsine Technologies Ltd146%
Physio-Control, Inc.63%
Philips Electronics North America Corporation21%
Avalign Technologies, Inc.10%
Cu Medical Systems, Inc.10%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LIFEPAK CR2HeartSine Samaritan PAD 450PHeartSine Samaritan PAD 350PAED PLUSPHILIPS HeartStart FRxHeartStartLIFEPAKAED 3ZOLL AED 3Lifeline VIEW 2DDU-100 Lifeline AED with RX form and cabinetDDU-2300 Lifeline VIEW with RX activation formDDU-100 Lifeline AED with RX activation formLifeline ViewLifelinePowerheart® AED G3 Plus Semi Automatic

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)204
MKJAutomated External Defibrillators (Non-Wearable)75
NSAOver-The-Counter Automated External Defibrillator1
KAEForceps, Ent1

GMDN & GCC registration

  • GMDN code 47910 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 86% · OTC 2%
  • 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 semi-automated external defibrillator products are registered in the US?

225 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-rechargeable public semi-automated external defibrillator", from 8 companies. The largest labeler is Zoll Medical Corporation with 75% of records.

Which FDA product codes apply?

MKJ (Automated external defibrillators (non-wearable)), MKJ (Automated External Defibrillators (Non-Wearable)), NSA (Over-The-Counter Automated External Defibrillator), KAE (Forceps, Ent)

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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