Aisys

GUDID 00840682102292

DATEX-OHMEDA INC

Anaesthesia workstation, general-purpose
Primary Device ID00840682102292
NIH Device Record Keyb59b02ee-c17e-4e53-8347-30496519ff06
Commercial Distribution StatusIn Commercial Distribution
Brand NameAisys
Version Model NumberCS2
Company DUNS129501685
Company NameDATEX-OHMEDA INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx
Phone+1(800)345-2700
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 56.66 KiloPascal and 106.66 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682102292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSZGas-machine, anesthesia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-12
Device Publish Date2015-09-23

On-Brand Devices [Aisys]

00840682102292CS2
00195278588128AISYS CS2 WITH ET CONTROL

Trademark Results [Aisys]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AISYS
AISYS
76607734 3085967 Live/Registered
CANON KABUSHIKI KAISHA
2004-08-19
AISYS
AISYS
76362578 3046547 Live/Registered
DATEX-OHMEDA, INC.
2002-01-24
AISYS
AISYS
74526553 1952346 Dead/Cancelled
Aisys Ltd.
1994-05-19

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