Empower MR Injector Head 017377

GUDID 37630039301010

Bracco Injeneering SA

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

• Primary Device ID: 37630039301010
• NIH Device Record Key: 307575e8-813b-4e80-afea-00a54f886218
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empower MR Injector Head
• Version Model Number: 017377
• Catalog Number: 017377
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	17630039301016 [Primary]
GS1	37630039301010 [Package]; Contains: 17630039301016; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062449

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: 2019-06-03
• Device Publish Date: 2019-05-24

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