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Device Explorer · FDA GUDID · GMDN 17882

Physiologic-monitoring defibrillation system

An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or

US‑registered devices295in commercial distribution
Companies7labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Physio-Control, Inc.27593%
Zoll Medical Corporation83%
Vive Health Llc41%
Remote Diagnostic Technologies Limited31%
Ming'S Mark Inc.31%
Schiller Ag10%
Jumax Healthcare Llc10%

Top labelers

CompanyDevicesShare
Physio-Control, Inc.27593%
Zoll Medical Corporation83%
Vive Health Llc41%
Remote Diagnostic Technologies Limited31%
Ming'S Mark Inc.31%
Schiller Ag10%
Jumax Healthcare Llc10%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tempus LS-MANUALLIFEPAK 35 Monitor/DefibrillatorLIFEPAK 15 MONITOR/DEFIBRILLATORLIFEPAK 15 Monitor/DefibrillatorLIFEPAK 20e Defibrillator/MonitorTempus LS-ManualLIFEPAK® 12 defibrillator/monitorLIFEPAK® 15 monitor/defibrillatorSHIP KIT-LP20, QUIK COMBOSHIP KIT-LP20, QUIK-COMBO, W/O REDI-PAKCodeManagement Module®NALIFEPAK® 20 and LIFEPAK 20e defibrillator/monitoRELI LIFEPAK 20ELIFEPAK 20 and LIFEPAK 20e defibrillator/monitorLIFEPAK 15 monitor/defibrillator

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)548
LDDDc-defibrillator, low-energy, (including paddles)125
DROPACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)125
DPSELECTROCARDIOGRAPH109
DPSElectrocardiograph14
DXNSystem, Measurement, Blood-Pressure, Non-Invasive7

GMDN & GCC registration

  • GMDN code 17882 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 86% · OTC 1%
  • 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.

No closely related category with 50+ devices.

How many physiologic-monitoring defibrillation system products are registered in the US?

295 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Physiologic-monitoring defibrillation system", from 7 companies. The largest labeler is Physio-Control, Inc. with 93% of records.

Which FDA product codes apply?

MKJ (Automated external defibrillators (non-wearable)), LDD (Dc-defibrillator, low-energy, (including paddles)), DRO (PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)), 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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