EmpowerCTA+ Injector System 017285

GUDID 47630039302014

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

Bracco Injeneering SA

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: 47630039302014
• NIH Device Record Key: 1af6e219-44f2-4b0c-90b0-87e8c49ce884
• 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: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	47630039302014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071378

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2023-10-25
• Device Publish Date: 2023-10-17

On-Brand Devices [EmpowerCTA+ Injector System]

• 47630039302014: Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
• 47630039301949: Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector