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Device Explorer · FDA GUDID · GMDN 38558

Primary battery

"A non-rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for

US‑registered devices105in commercial distribution
Companies19labelers on GUDID
Single‑use10%of device records
Sterile2%labelled sterile
Prescription40%Rx‑only share
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Share of device records

R & D Batteries, Inc.3029%
Cardiac Science Corporation1110%
Aed Battery Exchange, Llc99%
Zoll Medical Corporation99%
Physio-Control, Inc.88%
Defibtech, L.L.C.88%
Amco International Manufacturing & Design, Inc.77%
Philips Electronics North America Corporation44%

Top labelers

CompanyDevicesShare
R & D Batteries, Inc.3029%
Cardiac Science Corporation1110%
Aed Battery Exchange, Llc99%
Zoll Medical Corporation99%
Physio-Control, Inc.88%
Defibtech, L.L.C.88%
Amco International Manufacturing & Design, Inc.77%
Philips Electronics North America Corporation44%
Avertix Medical Inc.33%
Unipower Corporation33%
Aed Brands, Llc22%
Vita Heat Medical22%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Clarius Ultrasound ScannerMeniett™ Battery Pack, 9.6 VDCNAHeartStartLISO2,FAA,LITHIUM BATTERYLIFEPAK® 500 Li-SO2 Non-Rechargeable BatteryLIFEPAK 500 DPS Li-SO2 Non-Rechargeable BatteryAED Brands, LLCAED Battery ExchangeAMCOBattery Power SubassemblyBatteryAngelMed Guardian EXD Model EXD-001 BatteryBattery AED 3AED PLUSAED 3

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)46
MKJAutomated external defibrillators (non-wearable)41
FCOBOX, BATTERY, RECHARGEABLE7
MOQBattery, Replacement, Rechargeable5
QBIAcute coronary syndrome event detector3
LDDDc-Defibrillator, Low-Energy, (Including Paddles)3

GMDN & GCC registration

  • GMDN code 38558 · non‑implantable
  • Single‑use 10% · sterile 2% · Rx‑only 40% · OTC 29%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Pound) · 1

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How many primary battery products are registered in the US?

105 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Primary battery", from 19 companies. The largest labeler is R & D Batteries, Inc. with 29% of records.

Which FDA product codes apply?

MKJ (Automated External Defibrillators (Non-Wearable)), MKJ (Automated external defibrillators (non-wearable)), FCO (BOX, BATTERY, RECHARGEABLE), MOQ (Battery, Replacement, Rechargeable)

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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