ET CONTROL OPTION

GUDID 00195278579157

ET CONTROL OPTION

DATEX-OHMEDA INC

Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose
Primary Device ID00195278579157
NIH Device Record Keye81abc9c-e901-4620-a16e-5263946563e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameET CONTROL OPTION
Version Model NumberAISYS CS2
Company DUNS129501685
Company NameDATEX-OHMEDA INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278579157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QSFSoftware option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-29
Device Publish Date2022-07-21

Devices Manufactured by DATEX-OHMEDA INC

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00840682145596 - Carestation 7502023-04-12 CARESTATION 750 A1
00840682146425 - Carestation 750c2023-04-12 CARESTATION 750c A1
00840682143684 - IV POLE ASSY 12 IN2022-12-14 IV POLE 12 IN
00840682143691 - ROTATING IV POLE2022-12-14 ROTATING IV POLE
00840682143707 - IV POLE ASSY 24 IN2022-12-14 IV POLE 24 IN
00195278579157 - ET CONTROL OPTION2022-07-29ET CONTROL OPTION
00195278579157 - ET CONTROL OPTION2022-07-29 ET CONTROL OPTION

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