B125 V1.5 PATIENT MONITOR ATO MODEL Medical Device Identification

GUDID 00840682138581

B125 V1.5 PATIENT MONITOR ATO MODEL

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

General-purpose multi-parameter bedside monitor

Primary Device ID	00840682138581
NIH Device Record Key	ceac5488-c3b3-45bc-bec4-98ad6abeb79d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	B125 Patient Monitor
Company DUNS	784985108
Company Name	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
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	false
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

Operating and Storage Conditions

Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682138581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K201941

FDA Product Code

DPZ	Oximeter, ear

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2021-11-10
Device Publish Date	2020-11-16

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