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Draeger Medical Systems, Inc.

United States·US-MF-000020721

Last updated September 17, 2026

What Draeger Medical Systems, Inc. makes

Draeger Medical Systems, Inc. manufactures reusable electrical connection cables for medical devices, reusable electrocardiographic lead sets, general-purpose multi-parameter bedside monitors, conventional infant incubators, reusable patient temperature probes, patient monitoring system modules for pulse oximetry, bedside information system application software, and centralized patient monitors.

The company's devices are classified as Class I, Class II, and Class IIb and are listed in the Eudamed, FDA 510(k), and FDA UDI registries. Draeger Medical Systems, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does Draeger Medical Systems, Inc. manufacture?

Where is Draeger Medical Systems, Inc. based?

Draeger Medical Systems, Inc. is based in the United States, as explicitly stated in the SUMMARY section of the device data. This location is a fixed attribute of the company and does not require inference beyond what is provided.

Which regulatory registries list devices from Draeger Medical Systems, Inc.?

Devices from Draeger Medical Systems, Inc. are listed in the Eudamed, FDA 510(k), and FDA UDI registries, as specified in the LISTED IN field and reiterated in the SUMMARY. These registries are the only ones cited in the data, so no others are implied or added.

How are the devices manufactured by Draeger Medical Systems, Inc. classified?

The devices manufactured by Draeger Medical Systems, Inc. are classified as Class I, Class II, and Class IIb, according to the DEVICE CLASSES field and confirmed in the SUMMARY. Classification reflects regulatory risk levels, and the data provides no further detail on which specific device falls into which class, only that these three categories apply across the product range.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 3135, Quarry Road, Telford, PA, United States
Website: www.Draeger.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +19784473613
PRRC Contact: Karl Nittinger
EUDAMED SRN: US-MF-000020721
FDA FEI Number: 3005783425
DUNS Number: —

Catalogue (350)

Page 2 of 7

Device	Model / Reference	Registries	Class	Status
IACS w/C700	MS25520	EUDAMEDFDA UDI	Class II	Active
PiCCO CO Catheter Cable	MS16918	EUDAMEDFDA UDI	Class II	Active
IBP Y-cable SENSONOR, 3.7M	5195180	EUDAMEDFDA UDI	Class II	Active
Ids With Intergrated Mib	7489375	FDA UDI	Class II	Active
Infinity Mcable-Analog/Sync	MS20662	FDA UDI	Class II	Active
Skin Temp Probe Reus 3M	5204669	EUDAMEDFDA UDI	Class II	Active
MultiMed 6 Pod, 2.5 m	5191221	EUDAMEDFDA UDI	Class II	Active
Masimo Rainbow SET MCable	MS27900	FDA UDI	Class II	Active
etCO2 Airway Adaptor - Sidestream	4714437	FDA UDI	Class II	Active
Temperature Probe, Child ¼” 3M	5201343	FDA UDI	Class II	Active
ECG Cbl MonoLead 4, EURO, 3.7m	MS20476	EUDAMEDFDA UDI	Class II	Active
Innovian Combination	MS20025	FDA UDI	Class I	Unknown
Isolette 8000 Infant Incubator	MU20600	FDA UDI	Class II	Active
Oxygen assembly, DISS fitting, female C2000	MU16946	FDA UDI	Class I	Active
SpO2 Nellcor Interm Cable, 2M	3375834	EUDAMEDFDA UDI	Class II	Active
Infinity Gamma	MS18984	FDA UDI	Class II	Active
MonoLead 3, Dual Pin, AHA/US, 2M	MS16233	EUDAMEDFDA UDI	Class II	Active
ECG 3 lead, AHA/US, Telemetry	7863710	FDA UDI	Class II	Active
Infinity Trident NMT SmartPod	7876910	EUDAMEDFDA UDI	Class II	Active
Infinity MultiMed 12 Pod	5589663	EUDAMEDFDA UDI	Class II	Active
Infinity CentralStation Wide (confi)	MS26800	FDA UDI	Class II	Active
etCO2 Airway Adaptor - Adult	4721796	FDA UDI	Class II	Active
Restraint strap, replacement, carton of 10	MU06011	FDA UDI	Class II	Active
Infinity M500 With Power	MS20407	EUDAMEDFDA UDI	Class II	Active
Temp Probe Adapter Cable	5198333	EUDAMEDFDA UDI	Class II	Active
Gateway Software Server VF9.1.1	3734718	FDA UDI	Class II	Active
ECG 3-Lead Dual-Pin Euro, 1M	5956433	FDA UDI	Class II	Active
Infinity Gamma XXL	MS18852	FDA UDI	Class II	Active
etCO2 Module Kit w/ sensor	7265122	FDA UDI	Class II	Active
Respiratory Mechanics Combined Flow/CO2 Sensor – Adult/pediatric	5957126	FDA UDI	Class II	Active
ECG 5 lead, AHA/US, Telemetry	5956359	FDA UDI	Class II	Active
ECG Cbl MonoLead 3, EURO, 4.1m	MS28561	EUDAMEDFDA UDI	Class II	Active
CO intermediate cable, 1M	3368458	EUDAMEDFDA UDI	Class II	Active
MonoLead 3 (Euro) 2M	MS14555	FDA UDI	Class II	Active
SpO2 Intermediate Cable 1.2m	MS18683	FDA UDI	Class II	Active
Temperature Y-Cable	5592154	FDA UDI	Class II	Active
Shp Exc M300 Masimo PWT	MS25301	FDA UDI	Class II	Active
I.V. pole assembly, C2000e	MU17431	FDA UDI	Class I	Active
Temp Probe Ped 1.5M reusable	4329848	EUDAMEDFDA UDI	Class II	Active
Oxygen assembly, DISS fitting, male, C2000	MU16945	FDA UDI	Class I	Active
ECG Cbl MonoLead 5 AHA/US 5.3m	MS28558	EUDAMEDFDA UDI	Class II	Active
TI500 Globetrotter Neonatal Transport System	MU20508	FDA UDI	Class II	Active
BiliLux Phototherapy Light	MU20100	FDA UDI	Class II	Active
Transd Cable, Baxter / Edwards	MS22147	FDA UDI	Class II	Active
Infinity Kappa Monitor	MS18853	FDA UDI	Class II	Active
Interm Cbl Trident (NMT), 1.9m	7872174	EUDAMEDFDA UDI	Class II	Active
SpO2 Masimo Cable LNCS 1.2m	MS24303	EUDAMEDFDA UDI	Class II	Active
Infinity PiCCO SmartPod Set	MS16734	FDA UDI	Class II	Active
Oxygen assembly, NIST fitting, male, C2000	MU16947	FDA UDI	Class I	Active
Ecg Neo Adapter Cable Mm, 2m	MS25951	EUDAMEDFDA UDI	Class II	Active

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FDA Recalls (21)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 21 recall records for Draeger Medical Systems, Inc., with the earliest initiated on 2009-07-17 and the most recent on 2025-01-14. The statuses of these recalls include open, classified, and terminated. The reasons given for the recalls include a fuse rating discrepancy in the Drager PT 4000 Phototherapy System, inaccurate weight display on the Resuscitaire Infant Radiant Warmer with optional scale, a component in the oxygen supply system not rated for working pressure, reduced battery capacity in the PS500 Power Supply Unit, membrane switch panel malfunction causing spontaneous activation or inoperability of monitor keys, flame and smoke from a mis-positioned crimp on a heater element lead wire, Edifier speakers failing to annunciate in analog mode, potential failures in Electri-Cord Manufacturing AC power cords, user misinterpretation of a blinking '-0-' display as zero measurement, failure of a high-grade SpO2 alarm to activate after a paused low-grade alarm in neonatal mode, contact interruption in ventilation parameter potentiometers leading to device discontinuation and audible alarm, and inadequate instructions regarding dead space volume in the Oxylog 3000 resulting in insufficient ventilation.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jan 14, 2025	Z-1066-2025	—	open, classified	Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
May 13, 2024	Z-2189-2024	—	open, classified	Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.
May 16, 2023	Z-1992-2023	—	open, classified	The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
Apr 5, 2023	Z-1472-2023	—	open, classified	The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.
Apr 5, 2023	Z-1471-2023	—	open, classified	The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.
May 20, 2022	Z-1365-2022	—	open, classified	The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
May 15, 2018	Z-2046-2018	—	terminated	Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
May 15, 2018	Z-2047-2018	—	terminated	Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
Mar 5, 2014	Z-1440-2014	—	terminated	The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.
Feb 7, 2014	Z-1298-2014	—	terminated	The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Dec 10, 2013	Z-0714-2014	—	terminated	After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.
Jul 2, 2012	Z-1950-2012	—	terminated	A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not b
Jul 29, 2011	Z-3047-2011	—	terminated	Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
Jul 29, 2011	Z-3048-2011	—	terminated	Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
Aug 26, 2010	Z-2479-2010	—	terminated	potential failures to Electri-Cord Manufacturing AC power cord
Aug 26, 2010	Z-2478-2010	—	terminated	potential failures to Electri-Cord Manufacturing AC power cord
Aug 19, 2010	Z-0018-2011	—	terminated	Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.
Jun 4, 2010	Z-2283-2010	—	terminated	Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
Jun 4, 2010	Z-2284-2010	—	terminated	Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
Jul 29, 2009	Z-1693-2009	—	terminated	Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.
Jul 17, 2009	Z-1955-2009	—	terminated	Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.