EmpowerMR® Injector System without Remote Control 017377

GUDID 47630039300751

Composed of : 1 x Electro-Hydraulic Interconnect GTIN : 37630039300365 1 x Hydraulic Controller GTIN : 37630039300389 1 x Injector Head GTIN : 37630

Bracco Injeneering SA

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

• Primary Device ID: 47630039300751
• NIH Device Record Key: c008b92a-be34-4f06-8f94-1a7f970a5fa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmpowerMR® Injector System without Remote Control
• 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

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
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment

Device Identifiers

Device Issuing Agency	Device ID
GS1	47630039300751 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [EmpowerMR® Injector System without Remote Control]

• 47630039300751: Composed of : 1 x Electro-Hydraulic Interconnect GTIN : 37630039300365 1 x Hydraulic Controller
• 47630039300973: Composed of: 1 x Hydraulic Controller 1 x Injector Head 1 x Electro-Hydraulic Interconnect