NAMIC

Basic Information

• Brand Name: NAMIC
• Primary DI: H9656013193100
• Version / Model: 601319310
• Company Name: NAVILYST MEDICAL, INC.
• Labeler DUNS: 809699023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-06
• Public Version: 1
• Public Version Date: 2018-09-06
• Public Version Status: New
• Public Device Record Key: 8575c3f7-99eb-44ec-8cc4-ac9ae015c3b3

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	H9656013193101	HIBCC	BOX	10	In Commercial Distribution
Primary	H9656013193100	HIBCC

Customer Contacts

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