EmpowerCTA®+ Injector System 017285

GUDID 47630039300904

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

• Primary Device ID: 47630039300904
• NIH Device Record Key: febd5823-eadf-4cf3-afc4-3db50bb14372
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmpowerCTA®+ Injector System
• Version Model Number: 017285
• Catalog 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 environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment

Device Identifiers

Device Issuing Agency	Device ID
GS1	47630039300782 [Previous]
GS1	47630039300904 [Primary]
GS1	47630039301437 [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: 2019-11-05
• Device Publish Date: 2019-10-28

On-Brand Devices [EmpowerCTA®+ Injector System]

• 47630039300904: Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
• 47630039300782: Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Contro
• 47630039300430: Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Contro
• 47630039301000: Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector