ET CONTROL OPTION

Primary DI
00195278579157
Brand
ET CONTROL OPTION
Company
DATEX-OHMEDA INC
Model
AISYS CS2
Device description
ET CONTROL OPTION
Published
2022-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QSFSoftware option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSFSoftware Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic AgentsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210018000Et ControlDatex-Ohmeda, Inc., A General Electric Company2022-03-17QSF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278579157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278579157001952785791571952785791570195278579157

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia workstation, general-purposeAn assembly of electronic devices used for general inhalation anaesthesia (i.e., the delivery of oxygen (O2), nitrous oxide (N2O), other medical gases, and anaesthetic agents) and possibly total intravenous anaesthesia and local anaesthesia. Its main components are high, intermediate, and low pressure gas delivery systems, a breathing circuit (typically with a ventilator), and an anaesthetic gas scavenging system (AGSS). It has built-in alarms, analysers, control/monitoring systems, and typically has integrated circuitry/touchscreen displays for target controlled anaesthesia (TCA) for any type of patient (e.g., neonate, adult).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129501685
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682103947Carestation 650A12016-02-12
00840682103954Carestation 650cA12016-02-12
00840682103985Carestation 620A12016-02-12
00840682111317TEC 7VAP SEV 8% EASY-FIL EN2016-06-01
00840682111324TEC 7VAP HAL 5% EASY-FIL ES LATIN AMERICA2016-06-01
00840682111508TEC 7VAP SEV 8% EASY-FIL ES LATIN AMERICA2016-06-01
00840682111614TEC 7VAP SEV 8% EASY-FIL EN A12016-06-01
00840682111751TEC 7VAP SEV 8% QUIK-FIL EN2016-06-01
00840682112659TEC 6 PLUSVAP DES 220/240V EN2016-06-01
00840682123983Aladin2SEV CLOSED-FILL2018-02-27
00840682123990Aladin2SEV CLOSED-FILL2018-02-15
00840682124720TEC820 SEV2018-03-12
00840682124737TEC850 SEV2018-03-12
00840682124744TEC820 ISO2018-03-12
00840682124751TEC850 ISO2018-03-12
00840682134880NAABS ABSORBENT CANISTER REUSABLE2018-01-18
00840682111300TEC 7VAP ISO 5% EASY-FIL EN2016-06-01
00840682111003TEC 7VAP HAL 5% EASY-FIL EN2016-06-01
00840682111393TEC 7VAP ISO 5% EASY-FIL ES LATIN AMERICA2016-06-01
00840682100274Aladin2ENF EASY-FIL2015-09-23