Datex-Ohmeda, Inc.

Registration Details

Registration Name: Datex-Ohmeda, Inc.
Registration Number: 2112667
FEI Number: 2112667
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 3030 Ohmeda Drive
City: MADISON
State: WI
ZIP: 53718
Country: US

Regulatory Submissions

510(k) Number: K925580
PMA Number: P210018

Owner / Operator

Firm Name: GE HealthCare Technologies Inc.
Operator Number: 9912004
Address: 3000 N. Grandview Blvd
City: Waukesha
State: WI
Postal Code: 53188
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Gas-Machine, Anesthesia	BSZ	Class 2	Anesthesiology	No	2013-08-05
Vaporizer, Anesthesia, Non-Heated	CAD	Class 2	Anesthesiology	No	2013-08-05
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	Class 1	Anesthesiology	No	2002-04-12
Ventilator, Continuous, Facility Use	CBK	Class 2	Anesthesiology	No	1977-12-15
Compressor, Air, Portable	BTI	Class 2	Anesthesiology	No	2021-05-27
Absorber, Carbon-Dioxide	BSF	Class 1	Anesthesiology	No	2002-04-12
Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents	QSF	Class 3	Unknown	No	2022-06-16
Apparatus, Gas-Scavenging	CBN	Class 2	Anesthesiology	No	2014-01-02

Proprietary Names

Tec 6 Continuous Flow Vaporizer Tec 6 NAD Tec 6 Tec 6 Vaporizer iVent Circuits Gas exhaust line, white conical, disposable, 2m/6.6 ft, 5514184 Gas exhaust line, white conical and Colder, disposable, 0.18 m/7 in, 5514183 Gas exhaust line, white conical and Colder, disposable, 1 m/3.3 ft, 5514182 Tec 7 Anesthesia Vaporizer Avance CS2 Avance CS2 Carestation GE Datex-Ohmeda Aisys CS2 Anesthesia System Aisys CS2 Carestation Enhanced Aladin Cassette ALADIN2 DES FIXED-FIL ALADIN2 SEV QUIK-FIL ALADIN2 SEV EASY-FIL ALADIN2 DES SAF-FIL ALADIN2 ISO EASY-FIL Aladin2 ALADIN2 SEV EASY-FIL A EAC ALADIN2 DES SAF-FIL B Aisys CS2 ALADIN2 SEV QUIK-FIL A ALADIN2 ENF-EASY-FIL ALADIN2 SEV EASY-FIL B Aisys CS2 with Et Control Aisys Amingo GE DATEX-OHMEDA ENGSTROM CARESTATION Evair Engstrom Carestation Avance CS2 Anesthesia System GE Datex-Ohmeda Avance CS2 Anesthesia System Aisys Carestation GE Datex-Ohmeda Aespire 7900 S/5 Aespire 7900 Aespire 7900 CARESCAPE R860 Ventilator R860 CARESCAPE R860 Tec 850 Tec 820 ISO Tec 850 ISO Tec 820 Tec 800 series Tec 850 SEV Tec 820 SEV Tec 8 Aestiva MRI Aestiva/5 MRI 2VAP W/ARTICULATING ARM Aestiva/5 7900 Aestiva/5 with 7900 Ventilator Aestiva 7900 Datex-Ohmeda Aestiva/5 GE Datex-Ohmeda Aestiva 7900 AESTIVA GOLDSEAL 3VAP W/ARTICULATING ARM GE Datex-Ohmeda Aestiva/5 7900 Anesthesia System Datex-Ohmeda Aestiva/5 7900 Anesthesia System DATEX-OHMEDA ANESTHESIA VAPORIZER MODEL D-TEC Engstom Pro ENGSTROM PRO Ventilators GE Datex-Ohmeda ENGSTROM CARESTATION Engstrom Pro Aespire 7100/100 DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER Aespire View Tec 6 Plus Anesthesia Vaporizer S/5 Avance S/5 Avance Carestation Avance Carestation Avance Avance CS S/5 Avance Anesthesia System Avance CS2 Pro 7100 Ventilator Aespire 100; S/5 Aespire 7100 Datex-Ohmeda Aestiva/5 with 7100 Ventilator S/5 Aespire with 7900 Ventilator GE Datex Ohmeda Aespire 7900 S/5 Aespire Aespire 7100 Aestiva/5 Compact Aestiva/5 7100 Avance Anesthesia System Aestiva 7100 Compact GE Datex-Ohmeda Aestiva/5 GE Datex Ohmeda Aespire View Carestation 750 Carestation 750c Carestation 750/750c Carestation 750 A1 Carestation 750c A1 Multi-Absorber canister reusable Absorber canister assembly ABS Reusable Absorbent Canister Reusable Absorber Canister Reusable Absorbent Canister Reusable CO2 Absorber Canister Multi Absorber Canister CBS Reusable Absorbent Canister reusable Centiva/5 Centiva 6 Ventilator Avance 6.x Aespire 100 with 7100 Ventilator End-tidal (Et) Control ETC Et Control End-Tidal Control Carestation 650c Carestation 620 Carestation 650 A1 Carestation 620 A1 Carestation 620/650/650c Carestation 650 Carestation 650c A1 Avance 5.x

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only