Vevo MD Imaging System 51476

GUDID 00841517110123

Diagnostic ultrasound system

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

Primary Device ID	00841517110123
NIH Device Record Key	5e45477d-015c-40b1-816f-570df7dbc28a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vevo MD Imaging System
Version Model Number	51476-55
Catalog Number	51476
Company DUNS	014438860
Company Name	FUJIFILM SONOSITE, INC.
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

Operating and Storage Conditions

Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517110123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160674

FDA Product Code

ITX	Transducer, Ultrasonic, Diagnostic

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	2023-12-19
Device Publish Date	2023-12-11

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