Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029871637

FEI Number

3029871637

Entity Name

ZOLL International Holding B.V.

City/State/Country

Elst Gelderland, NL

Establishment Address

Einsteinweg 8A, Elst Gelderland 6662 PW, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ZOLL Medical Corporation (Owner Number: 1220908)

Owner / Operator Contact Address

269 MILL ROAD, Chelmsford, MA 01824, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P160022

All Registered Proprietary Names

Eagle II EMV+ 731 Series Z Vent AEV Autopulse Resuscitation System Model 100 ICY Intravascular Heat Exchange Catheter Coolgard 3000 Console Cool Line Intravascular Heat Exchange Catheter Solex 7 Intravascular Heat Exchange Catheter Quattro Intravascular Heat Exchange Catheter Start-Up Kit Thermogard XP Console ZOLL Code Writer TherOx SSO2 Catheter TherOx DownStream Console TherOx DownStream Cartridge TherOx DownStream Console, Refurbished ACCUVENT SENSOR DISPOSABLE FLOWTUBE, ACCUVENT FLOW SENSOR CONNECTOR, ACCUVENT InnerCool STx+ Surface Pads Set MRI Roll Stand Roll Stand Thermogard Vest S/M Thermogard HQ Thermogard XP Temperature Management System Thermogard Surface System Surface Start-Up Kits Surface Temperature Management System Thermogard XP Refurbished STx Vest L/XL Thermogard HQ Refurbished Thermogard XP STx Surface Pads Thermogard HQ Temperature Management System Thermogard HQ Surface Start-Up Kit (TGHQ-SURF) STx Vest S/M Thermogard Vest L/XL STx Surface Pad Surface Start-Up Kit (CG-SURF)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2022-12-19
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2017-05-17
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-02-07
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-02-07
OVR	Kit, First Aid, Talking	General, Plastic Surgery	Class 1	878.4014	2020-11-10
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2023-08-03
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2013-12-06
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2023-12-11
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2014-04-10
MWG	System, Oxygen, Aqueous	Unknown	Class 3	N/A	2023-07-17
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2026-05-12
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2019-11-21
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2019-11-21
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2022-06-08
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2022-11-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-11-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-11-09
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-11-09
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-11-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-11-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-11-09
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-11-09
FOH	Mattress, Water, Temperature Regulated	General Hospital	Class 1	880.5560	2014-12-04
PIZ	Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve	Unknown	Class 3	N/A	2019-11-21
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2016-10-12
NZE	Hyperthermia Monitor	Cardiovascular	Class 2	870.5900	2023-11-16
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	Class 2	870.5900	2017-05-12
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2017-05-31
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2025-11-25
NZE	Hyperthermia Monitor	Cardiovascular	Class 2	870.5900	2025-11-25
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2018-01-18

Official Correspondent

Paul Dias

US Agent Details

Paul Dias Business: ZOLL MEDICAL CORPORATION Email: fis@zoll.com Phone: (978) 4219413

Related Public Records

Same Entity

ZOLL Medical Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1218058	ZOLL Medical Corporation	Pawtucket, RI, US
2112020	ZOLL Medical Corporation	DEERFIELD, WI, US
2021710	ZOLL Palm Springs	Palm Springs, CA, US
3038259592	ZOLL MEDICAL CORPORATION	Wilmington, MA, US
3010617000	ZOLL Circulation, Inc.	San Jose, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK 500 AED.
Z-0004-2017	Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria	3	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.
Z-0011-2013	Philips Healthcare Inc.	3	Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

Similar Registrations

Registration Number	Establishment Name	Location
2112020	ZOLL Medical Corporation	DEERFIELD, WI, US
3010030355	PHYSIO-CONTROL MAASTRICHT, INC.	Maastricht Limburg, NL
3015876	PHYSIO-CONTROL, INC.	Redmond, WA, US
3017422354	EMI (DONGGUAN) ASIA LIMITED	Dongguan City Guangdong, CN
3011823740	Greatbatch Medical S. de R.L. de C.V.	Tijuana Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029871637. Last updated year: 2026. Please use registration number 3029871637 when referencing this establishment in official correspondence.