Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014220748

FEI Number

3014220748

Entity Name

Datex-Ohmeda, Inc.

City/State/Country

Wauwatosa, WI, US

Establishment Address

9900 Innovation Drive, Wauwatosa, WI 53226, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251663

PMA Number

N/A

All Registered Proprietary Names

Giraffe Incubator Carestation CS1 IV Pole ROTATING IV POLE Rotating IV1 IV POLE ASSY 12 IN 12 Inch IV1 IV POLE ASSY 24 IN 24 Inch IV1 LULLABY IV POLE IV1 Novii Patch Novii Wireless Patch System Novii Panda Warmer Giraffe Warmer Giraffe Warmer Panda Freestanding Warmer Panda Wall Mount Warmer Panda Ires Warmer Disposable Infant Skin Temperature Probe Giraffe Panda Disposable Infant Skin Temperature Probe Panda Warmer Giraffe Warmer Panda iRes Warmer Panda Warmer StAR Giraffe Stand-alone Infant Resuscitation System (Bag and Mask) Giraffe and Panda Bag and Mask Resuscitation System Giraffe Stand-alone Infant Resuscitation System Novii+ Wireless Patch System Novii+ Interface Novii+ Pod Pressure Diffusing Mattress GIRAFFE PRESSURE DIFFUSING MATTRESS Giraffe OmniBed + Shuttle Giraffe Omnibed Giraffe Shuttle Giraffe OmniBed BiliSoft 2 Phototherapy System BiliSoft LED Phototherapy System BiliSoft BiliSoft Phototherapy System Giraffe Incubator Carestation CS1 Giraffe Incubator Carestation Giraffe Panda Disposable Infant Skin Temperature Probe Disposable Infant Skin Temperature Probe Giraffe Incubator + Shuttle Giraffe Shuttle Giraffe Incubator Giraffe Stand-alone Infant Resuscitation System (T-piece) StAR Giraffe Stand-alone Infant Resuscitation System (T-piece, and Bag and Mask) Giraffe Warmer Panda Warmer Panda iRes Warmer Giraffe Stand-alone Infant Resuscitation System Novii Novii Wireless Patch System Novii Interface Novii Pod Giraffe Warmer Panda iRes Warmer Panda Warmer Giraffe Panda Disposable Infant Skin Temperature Probe Giraffe Warmer Panda iRes Disposable Infant Skin Temperature Probe Blue Spot PT Giraffe Blue Spot PT Lite Blue Spot PT Lite ECG Trunk Cables and Leadwires Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables) ECG Adapter Cable NOVII INTERFACE CABLE - GE FECG MECG Cable FECG Cable CLAB ECG Trunk Cable 12-lead AHA 10ft CLAB ECG Trunk Cable 12-lead IEC 10ft NOVII INTERFACE CABLE - GE MECG Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA) 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in. NOVII INTERFACE CABLE - GE UA 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC long, 3.6 m Cable assembly ECG 3 lead neo AHA short, 1.8 m Cable assembly ECG 3 lead neo AHA long, 3.6 m 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC short, 1.8 m 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in. 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in. Giraffe Omnibed Carestation CS1 Giraffe Incubator Carestation CS1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2022-03-04
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2007-01-09
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2017-12-15
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2010-12-07
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2013-02-11
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2007-12-21
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2010-07-28
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2023-12-14
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2005-06-28
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2010-12-07
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2010-08-26
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2010-08-26
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2018-07-30
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2016-01-12
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2010-12-07
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2009-07-16
OSP	Uterine Electromyographic Monitor	Obstetrics/Gynecology	Class 2	884.2720	2017-12-15
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2010-07-28
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2021-02-19
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2018-01-10
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2018-06-06
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2025-12-03
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2025-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GE HealthCare Technologies 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
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K943360	Ohmeda Medical	OHIO CARE PLUS INCUBATOR	1994-09-29
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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%).
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.

Similar Registrations

Registration Number	Establishment Name	Location
3005652389	ATOM MEDICAL CORPORATION	Sakura-ku, Saitama-shi, JP
3036470679	Datex-Ohmeda, Inc.	Waukesha, WI, US
3021559257	CAF MEDICAL SOLUTIONS INC	Hockley, TX, US
1054241	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US
3007734888	WIPRO GE HEALTHCARE PRIVATE Ltd.	BANGALORE Karnataka, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014220748. Last updated year: 2026. Please use registration number 3014220748 when referencing this establishment in official correspondence.