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
00840682119320Well Baby BassinetBN42016-07-29
00840682119337Well Baby BassinetBN72016-07-29
00840682119344Well Baby BassinetBN32016-07-29
00840682119375Well Baby BassinetBN12016-07-29
00840682119399Well Baby BassinetBN22016-07-29
00840682119429Well Baby BassinetBN62016-07-29
00840682119436Well Baby BassinetBN92016-07-29
00840682119467Well Baby BassinetBN82016-07-29
00840682119481Well Baby BassinetBN102016-07-29
00840682119498Well Baby BassinetBN52016-07-29
00840682102353Aestiva GS7900 2 vap art arm2015-09-23
00840682102261Aespire79002015-09-23
00840682102285AespireView2015-09-23
00840682102308Aestiva79002015-09-23
00840682102339AestivaMRI2015-09-23
00840682102360Aestiva GS7900 3 vap art arm2015-09-23
00840682145596Carestation 750A12023-04-04
00840682146425Carestation 750cA12023-04-04
00195278588128AisysCS2 WITH ET CONTROL2022-07-21
00840682102322AvanceCS22015-09-23