Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2510954

FEI Number

2510954

Entity Name

DRAEGER MEDICAL SYSTEMS, INC.

City/State/Country

Telford, PA, US

Establishment Address

3135 QUARRY RD., Telford, PA 18969, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Draeger Medical Systems, Inc. (Owner Number: 9070398)

Owner / Operator Contact Address

6 Tech Drive, Andover, MA 01810, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K941106

PMA Number

N/A

All Registered Proprietary Names

RW Resuscitaire TI500 Globetrotter Transport System Isolette 8000 plus Infant Incubator BiliLux Phototherapy Light Isolette 8000 plus Babyroo TN300 TI500 Isolette Infant Incubator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2013-12-03
FPL	Incubator, Neonatal Transport	General Hospital	Class 2	880.5410	2007-12-14
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2018-05-02
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2018-05-02
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2018-11-26
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2025-01-29
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2023-05-31
FPL	Incubator, Neonatal Transport	General Hospital	Class 2	880.5410	2007-12-14

Official Correspondent

Melissa Gray

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Draeger Medical Systems, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005783425	DRAEGER MEDICAL SYSTEMS, INC.	ANDOVER, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K020219	Replacement Parts Industries, Inc.	RPI SKIN OR AIR TEMPERATURE PROBE	2002-04-12
K881713	Gempco, Inc.	SPECIAL PROCEDURES BASE UNIT MODEL 500	1988-07-12
K943360	Ohmeda Medical	OHIO CARE PLUS INCUBATOR	1994-09-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0041-2020	Ohmeda Medical	2	Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2510954. Last updated year: 2026. Please use registration number 2510954 when referencing this establishment in official correspondence.