Remote Control

Basic Information

• Brand Name: Remote Control
• Primary DI: 17630039301030
• Version / Model: 017380
• Catalog Number: 017380
• Company Name: Bracco Injeneering SA
• Labeler DUNS: 482489007
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-24
• Public Version: 1
• Public Version Date: 2019-06-03
• Public Version Status: New
• Public Device Record Key: 8342bb11-d4b1-474d-a44c-e28ee5436f21

Device Description

Empower MR Remote Control - 1731

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36968	Contrast medium injection system control unit	A mains electricity (AC-powered) electronic device that may be a component of a contrast medium injector system and designed to initiate and terminate the operation of a contrast medium injection procedure from a remote location (e.g., the shielded operators control room).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37630039301034	GS1	BOX	1	In Commercial Distribution
Primary	17630039301030	GS1

Premarket Submissions

Submission Number	Supplement Number
K062449	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dry environment