Is this your brand? Sign in to claim ownership.

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 7 of 7

Device	Model / Reference	Registries	Class	Status
Infinity Multiview Infinity Telemetry System	K060223	FDA 510(k)	Class II	Active
BiliLux	K172656	FDA 510(k)	Class II	Active
Infinity Delta/Delta Xl/ Kappa/ Gamma X Xl/ Vista Xl/ Sc7000/Sc8000/ Sc9000xl	K070566	FDA 510(k)	Class II	Active
Infinity Cnap Smartpod	K102968	FDA 510(k)	Class II	Active
Isolette 8000 plus	K172154	FDA 510(k)	Class II	Active
Infinity CentralStation Wide	K240312	FDA 510(k)	Class II	Active
Infinity M300	K200859	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Infinity Monitors With Scio Modifications	K051628	FDA 510(k)	Class II	Active
Infinity Gateway Suite	K203579	FDA 510(k)	Class II	Active
Infinity Explorer Software, C700 For It Patient Vicinity Workstation	K141756	FDA 510(k)	Class II	Active
Infinity Modular Monitors Vf4 Modifications	K033694	FDA 510(k)	Class II	Active
Infinity Alpha	K051658	FDA 510(k)	Class II	Active
Infinity Modular Monitors Vf4 Modifications With Scio, Models Delta, Delta Xl, Kappa, Sc 8000, Sc 7000, Sc 9000xl	K033957	FDA 510(k)	Class II	Active
Draeger Jaundice Meter Jm-105	K133175	FDA 510(k)	Class I	Active
Draeger Micro2+ And Masimo Minisat	K032537	FDA 510(k)	Class II	Active
Infinity Trident Nmt Pod	K042003	FDA 510(k)	Class II	Active
Infinity Picco Pod, Model Ms16734	K073113	FDA 510(k)	Class II	Active
Globe-Trotter Gt5400	K141565	FDA 510(k)	Class II	Active
Infinity Nellcor Oximax Smartpod, Model Ms23997	K082888	FDA 510(k)	Class II	Active
Isolette 8000 Plus	K182977	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Modification To Infinity Explorer	K060254	FDA 510(k)	Class II	Active
Infinityedical Information Bus (mib/Mib Ii And Mib Duo) Protocol Converter	K033807	FDA 510(k)	Class II	Active
Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device	K103625	FDA 510(k)	Class II	Active
Infinity Gamma/Gammaxl And Vista With Vf5	K042656	FDA 510(k)	Class II	Active
Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set	K113798	FDA 510(k)	Class II	Active
Infinity CentralStation Wide	K151860	FDA 510(k)	Class II	Active
Infinity Gamma	K041087	FDA 510(k)	Class II	Active
Infinity Kappa Xlt	K042904	FDA 510(k)	Class II	Active
Infinity Telesmart Telemetry System	K061379	FDA 510(k)	Class II	Active
Draeger Medical Information Bus (mib, Mib Ii, Mib Duo) Protocol Converters	K050974	FDA 510(k)	Class II	Active
Infinity CentralStation Wide, Infinity M300, Infinity M300+	K231477	FDA 510(k)	Class II	Active
Infinity Gamma / Gammaxl, Infinity Vista	K053484	FDA 510(k)	Class II	Active
Babyroo TN300	K230278	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Modification To Infinity Explorer	K040945	FDA 510(k)	Class II	Active
Babyroo TN300	K243606	FDA 510(k)	Class II	Active
Infinity Delta And Kappa Series Monitors With Vf6 Modifications	K060039	FDA 510(k)	Class II	Active
Infinity Gammaxl	K033600	FDA 510(k)	Class II	Active
Infinity Delta, Infinity Delta XL, Infinity Kappa	K152407	FDA 510(k)	Class II	Active
Infinity Masimo Set Sp02 Pod	K061329	FDA 510(k)	Class II	Active
Resuscitaire With Autobreath	K120642	FDA 510(k)	Class II	Active
Infinity Acute Care System (IACS) Monitoring Solution	K201764	FDA 510(k)	Class II	Active
Infinity Multiview Infinity Telemetry System	K033305	FDA 510(k)	Class II	Active
Nanoblutm 500	K113206	FDA 510(k)	Class II	Active
Infinity Modular Monitors With Vf5 Modifications (delta/Kappa/Delta Xl/Vista Xl/Gamma X Xl And Sc 7000/8000/9000xl	K043439	FDA 510(k)	Class II	Active
Infinity Centralstation With Infinity M300	K130711	FDA 510(k)	Class II	Active
Infinity Gateway Suite	K233834	FDA 510(k)	Class II	Active
Infinity Gateway Suite, Vf4	K043549	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Infinity Acute Care System (iacs) Monitoring Solution	K093788	FDA 510(k)	Class II	Active
Infinity Gammaxl And Sc 6802xl With The Scio Gas Module	K040188	FDA 510(k)	Class II	Active
Infinity Acute Care System (IACS) Monitoring System	K203088	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.