Navigator Bionavigation System

Basic Information

• Brand Name: Navigator Bionavigation System
• Primary DI: 10815149025329
• Version / Model: 60-3020
• Catalog Number: 60-3020
• Company Name: CORPAK MEDSYSTEMS, INC.
• Labeler DUNS: 147530323
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-04
• Public Version: 3
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: 8cc4e9d2-c3cf-4b71-8397-8d585c247a16

Device Description

catheter locating system

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
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44119	Intravascular catheter stylet magnet detector	An electrically-powered device designed to rapidly detect and confirm the location and orientation of the tip of a compatible, peripherally-inserted central catheter (PICC) or central venous catheter (CVC) stylet containing one or more small, specially-oriented magnets encapsulated at the distal end. It provides rapid feedback to healthcare personnel on the positioning of the catheter/stylet during initial placement.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815149025329	GS1

Customer Contacts

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