EmpowerCTA®+ Injector System 1731 ed03

GUDID 47630039301444

Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector

Bracco Injeneering SA

CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary CT contrast medium injection system, line-powered, stationary

• Primary Device ID: 47630039301444
• NIH Device Record Key: 555a4765-2e0f-4fe7-8efc-09c5bdf15a9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmpowerCTA®+ Injector System 1731 ed03
• Version Model Number: 017285
• Company DUNS: 482489007
• Company Name: Bracco Injeneering SA
• 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

• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *dry environmentl

Device Identifiers

Device Issuing Agency	Device ID
GS1	47630039301444 [Primary]

FDA Product Code

• IZQ: Injector, Contrast Medium, Automatic

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: 2020-05-13
• Device Publish Date: 2020-05-05

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• 37630039301980 - IV Pole: 2024-03-11
• 37630039301997 - Floor Stand: 2024-03-11
• 47630039301949 - EmpowerCTA+ Injector System: 2024-02-13 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
• 47630039302014 - EmpowerCTA+ Injector System: 2023-10-25 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
• 37630039301713 - Patient Set: 2022-01-24 Patient Set DEHT to be used with CT Exprès injectors