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Device Explorer · FDA GUDID · GMDN 48048

Rechargeable professional 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 devices1,122in commercial distribution
Companies2labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Zoll Medical Corporation1,120100%
Philips Medical Systems Hsg20%

Top labelers

CompanyDevicesShare
Zoll Medical Corporation1,120100%
Philips Medical Systems Hsg20%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

X SERIESR SeriesNAONESTEP PEDIARIC CPR MULTI-FUNCTION ELECTRODE, SPROPAQ MDR SERIESAED PROZENIXPROPAQ MX SERIES MONITOR/DEFIBRILLATORX SeriesE SERIESTubingCableCuffsHose

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)2,170
DROPACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)268
LLDPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL259
DPSELECTROCARDIOGRAPH259
MKJAutomated External Defibrillators (Non-Wearable)123
DSKCOMPUTER, BLOOD-PRESSURE37

GMDN & GCC registration

  • GMDN code 48048 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 95% · 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 rechargeable professional automated external defibrillator products are registered in the US?

1,122 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rechargeable professional automated external defibrillator", from 2 companies. The largest labeler is Zoll Medical Corporation with 100% of records.

Which FDA product codes apply?

MKJ (Automated external defibrillators (non-wearable)), DRO (PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)), LLD (PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL), DPS (ELECTROCARDIOGRAPH)

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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