What is FDA product code MKJ?

This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

Henry Schein · Automated External Defibrillators (Non-Wearable) → Cardiovascular

Name: Henry Schein
Brand: Henry Schein

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MKJ
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
EMI (Dongguan) Asia Limited	Dongguan	Guangdong	Contract manufacturer	9

Record

Regulatory record for Henry Schein
Listed by	Henry Schein, Inc., United States
FDA product code	MKJ
Device type	Automated External Defibrillators (Non-Wearable)
Device class	Class 3
Regulation	21 CFR 870.5310
Record published	2016-02-12
Record revised	2023-02-20 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature -20 to 40 °C
Packaging	Pack of 10
Distribution end date	2019-03-06

Catalogue Numbers

Catalogue numbers for Henry Schein
Catalogue number	Size	Status
1127162		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
X Series	Zoll Medical Corporation	862
E Series	Zoll Medical Corporation	571
M Series	Zoll Medical Corporation	219
R Series	Zoll Medical Corporation	216
Lifepak® 15 monitor/defibrillator	Physio-Control, Inc.	188
AED Plus	Zoll Medical Corporation	124
Lifepak® 12 defibrillator/monitor	Physio-Control, Inc.	122
Lifepak CR Plus and Lifepak Express defibrillators	Physio-Control, Inc.	111
M Series Biphasic	Zoll Medical Corporation	111
PadPro	ConMed Corporation	96
R&D Batteries, Inc.	R & D Batteries, Inc.	71
Lifepak® 20 and Lifepak 20e defibrillator/monitors	Physio-Control, Inc.	59

Showing 12 of 312. All products under Automated External Defibrillators (Non-Wearable)

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P160008	2026-05-07	HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories	Heartsine Technologies, Ltd
P170018	2025-11-06	LIFEPAK® CR2 Automated External Defibrillator	Physio-Control, Inc.
P160032	2025-07-03	Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E	Defibtech, LLC
P210015	2025-01-29	Avive Automated External Defibrillator (AED) System	Avive Solutions Inc
P200005	2024-01-09	TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors	TZ Medical, Inc.
P200007	2023-06-23	HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads	Graphic Controls D.B.A. Vermed
P200004	2022-06-16	ConMed PadPro Multifunction Electrodes	ConMed Corporation
P160012	2021-07-08	Infant/Child Reduced Energy Defibrillation Electrodes	Physio-Control, Inc.
P160033	2021-06-14	Powerheart G5 AED	Zoll Medical Corporation
P190013	2021-02-02	AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)	AED Battery Exchange, LLC
P180028	2020-08-22	HeartStart FRx Defibrillator	Philips Medical Systems Technologies Ltd
P190007	2020-08-07	Cardinal Health Multifunctional Defibrillation Electrode	Cardinalhealth
P160022	2020-06-11	X Series and Propaq MD	Zoll Medical Corporation
P160015	2020-06-05	AED 3 Defibrillator with Uni-Padz	Zoll Medical Corporation
P160028	2020-05-11	Philips HeartStart FR3 Defibrillator	Philips Medical Systems Technologies Ltd
P160026	2020-02-13	LIFEPAK Automated External Defibrillators (AEDs)	Physio-Control, Inc.
P160034	2019-08-20	Powerheart® G3 Pro AED	Zoll Medical Corporation

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Henry Schein