00840682103008 Medical Device Identification

GUDID 00840682103008

GE Healthcare Finland Oy

Pulse oximeter probe, reusable

Primary Device ID	00840682103008
NIH Device Record Key	c7058c15-e330-4288-98a3-ae5a6cab3b22
Commercial Distribution Status	In Commercial Distribution
Version Model Number	OXISMART, 3M ,2006644-001
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	false
Manufacturing Date	false
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
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
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 Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682103008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K011000

FDA Product Code

MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-06-16

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