Remote Control 017380

GUDID 37630039301034

Empower MR Remote Control - 1731

Bracco Injeneering SA

Contrast medium injection system control unit

• Primary Device ID: 37630039301034
• NIH Device Record Key: 8342bb11-d4b1-474d-a44c-e28ee5436f21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remote Control
• Version Model Number: 017380
• Catalog Number: 017380
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	17630039301030 [Primary]
GS1	37630039301034 [Package]; Contains: 17630039301030; 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

On-Brand Devices [Remote Control]

• 37630039300785: EmpowerMR 17" Remote 1721
• 37630039300471: EmpowerCTA+ 17" Remote 1722
• 37630039300372: EmpowerMR 17" Remote 1722
• 37630039301034: Empower MR Remote Control - 1731
• 37630039301416: EmpowerCTA+ 17" Remote 1721
• 37630039300983: EmpowerCTA+ 17" Remote 1731
• 37630039302048: EmpowerCTA+ Injector System, Remote Control