NAMIC

Basic Information

• Brand Name: NAMIC
• Primary DI: H965904008390
• Version / Model: 90400839
• Company Name: NAVILYST MEDICAL, INC.
• Labeler DUNS: 809699023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6eeffc39-7ec4-482e-aee4-3bda1e2de3d8

Device Description

CONTRAST CONTROLLER

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZI	System, x-ray, angiographic	Radiology	892.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36310	Contrast medium conservation system	An assembly of electromechanical devices that serves a contrast medium injector system by controlling the amount of contrast agent supplied to the syringe/injector portion of the contrast medium injector system. It is designed to optimise the use of injectible contrast agents in order to prevent unnecessary waste of contrast media during and/or between patient procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H965904008391	HIBCC	BOX	25	In Commercial Distribution
Primary	H965904008390	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K903493	000