Hokanson

Basic Information

• Brand Name: Hokanson
• Primary DI: 00817065021143
• Version / Model: 5.40
• Catalog Number: 03412
• Company Name: D.E.HOKANSON, INC.
• Labeler DUNS: 071829634
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 5
• Public Version Date: 2020-10-02
• Public Version Status: Update
• Public Device Record Key: 24403320-fdb6-41f0-bd87-cd6c7454e038

Device Description

ARTERIAL AND VENOUS EXAM SOFTWARE - 110V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, a recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease in the patient. Includes interface box to connect computer to physiologic instruments and 110V mains.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
DQK	Computer, Diagnostic, Programmable	Cardiovascular	870.1425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47688	Peripheral vascular haemodynamic measurement application software	An application software program designed for use with a noninvasive peripheral vascular haemodynamic measuring device (e.g., cardiovascular-risk peripheral arterial tonometry system, plethysmograph, sphygmomanometer) to enable the management and/or analysis of data; it may also support control of the device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817065021143	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970570	000