NAMIC

Basic Information

• Brand Name: NAMIC
• Primary DI: H965813000210
• Version / Model: 81300021
• Company Name: NAVILYST MEDICAL, INC.
• Labeler DUNS: 809699023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d57302b4-7fd0-4fd1-923a-0165b5804b0e

Device Description

NAMIC 72" Sosa Spike Pressurized Fluid Delivery System

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: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35375	Stopcock	A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H965813000211	HIBCC	BOX	100	In Commercial Distribution
Primary	H965813000210	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	72	Inch