E-SCAIOE-00, MODULE ASSEMBLY Medical Device Identification

GUDID 00840682104135

E-SCAIOE-00, MODULE ASSEMBLY

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

Primary Device ID	00840682104135
NIH Device Record Key	2bc47552-ab64-4fd1-8946-9e3c74085b5a
Commercial Distribution Status	In Commercial Distribution
Version Model Number	E-sCAiOE-00
Company DUNS	401966697
Company Name	GE Healthcare Finland Oy
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682104135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K211171

FDA Product Code

NHP	Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-03-15
Device Publish Date	2022-03-07

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