EmpowerCTA®+ Injector System with EDA 017383

GUDID 47630039300812

Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 37630039300471 1 x EDA Module Kit GTIN : 37630

Bracco Injeneering SA

CT contrast medium injection system, line-powered, stationary

• Primary Device ID: 47630039300812
• NIH Device Record Key: d97ebe67-cf7e-4e0a-bb9f-e7e440aabaeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmpowerCTA®+ Injector System with EDA
• Version Model Number: 017383
• Catalog Number: 017383
• 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
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage 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 Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	47630039300447 [Previous]
GS1	47630039300812 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-26

On-Brand Devices [EmpowerCTA®+ Injector System with EDA]

• 47630039300812: Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control
• 47630039300447: Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control