CT Expres™ 3D 651207

GUDID 47630039300096

Composed of : 1 x CT Exprès™ - Injector Unit GTIN : 37630039300105 2 x CT Exprès™ - Control Panel GTIN : 37630039300112

Bracco Injeneering SA

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

• Primary Device ID: 47630039300096
• NIH Device Record Key: 1afe358d-4cc3-4341-9dd9-1fe4a0003159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT Expres™ 3D
• Version Model Number: 651207
• Catalog Number: 651207
• 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: true
• 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: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	47630039300096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151048

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by Bracco Injeneering SA

• 17630039301962 - Injector Head: 2024-05-06
• 17630039302037 - Injector Head: 2024-05-06
• 17630039301627 - FastLoad™ MR Syringe Pack: 2024-04-16
• 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