00840682104142 Medical Device Identification

GUDID 00840682104142

GE Healthcare Finland Oy

Patient monitoring system module, multiple-gas

Primary Device ID	00840682104142
NIH Device Record Key	5162a214-df54-46a4-863b-3177b9dc67d8
Commercial Distribution Status	In Commercial Distribution
Version Model Number	E-sCAiOV-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	false
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	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx
Phone	+1(800)558-5120
Email	xx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682104142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K150245

FDA Product Code

CBR	ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-07-09
Device Publish Date	2016-06-03

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