00840682110181 Medical Device Identification

GUDID 00840682110181

GE HEALTHCARE JAPAN CORPORATION

Extracorporeal ultrasound imaging transducer, hand-held

Primary Device ID	00840682110181
NIH Device Record Key	a43cc233-cbf3-4f8c-9c24-34fd3d0cc1a1
Commercial Distribution Discontinuation	2019-11-25
Commercial Distribution Status	Not in Commercial Distribution
Version Model Number	9L
Company DUNS	696021596
Company Name	GE HEALTHCARE JAPAN CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
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)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx

Operating and Storage Conditions

Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682110181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K052441

FDA Product Code

IYO	System, imaging, pulsed echo, ultrasonic

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	2020-05-05
Device Publish Date	2016-07-15

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