NAMIC

Basic Information

• Brand Name: NAMIC
• Primary DI: H749600104380
• Version / Model: 60010438
• Company Name: NAVILYST MEDICAL, INC.
• Labeler DUNS: 809699023
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-19
• Public Version: 2
• Public Version Date: 2018-12-28
• Public Version Status: Update
• Public Device Record Key: 0b9e2863-3dc5-4191-ab79-1a63095e8553
• Distribution End Date: 2018-12-27

Device Description

NAMIC Convenience Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
16545	Angiography kit	A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H749600104381	HIBCC	BOX	20	Not in Commercial Distribution	2018-12-27
Primary	H749600104380	HIBCC

Customer Contacts

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