GUDID 00840682104180

GE Healthcare Finland Oy

Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas Patient monitoring system module, multiple-gas
Primary Device ID00840682104180
NIH Device Record Key15a834dd-4cc3-4c2e-a071-7bea1137cd1c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberE-sCAiO-00
Company DUNS401966697
Company NameGE Healthcare Finland Oy
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(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682104180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBSANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-07-09
Device Publish Date2016-06-03

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