Hokanson

Basic Information

• Brand Name: Hokanson
• Primary DI: 00817065021204
• Version / Model: Indium Gallium Strain Gauge
• Catalog Number: 03355
• Company Name: D.E.HOKANSON, INC.
• Labeler DUNS: 071829634
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 5
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 6544e536-c53e-406b-b6e0-3ae8078a0f5c

Device Description

A plethysmograph sensor that attaches to a plethysmograph instrument, used to measure volume changes in a limb or digit. The sensor has a tube filled with electrically resistive fluid (indium-gallium), and is wrapped around the circumference of the limb or digit. The plethysmograph instrument measures the resistance changes of the sensor that occur when the resistive fluid column length changes according to circumference changes that occur with vascular flow changes.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• 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
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	870.2780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62333	Plethysmography strain transducer	A hoop-like device intended to be wrapped around a limb or digit and used in conjunction with a limb plethysmograph (not included) to determine volume variations in the extremities (e.g., legs, toes, arms, fingers) as modified by the circulation of blood through them. Often referred to as a strain gauge, it typically operates based on electrical resistance changes with length, and is used during assessment of a variety of clinical conditions (e.g., endothelial dysfunction, reactive hyperemia, deep vein thrombosis) and for a number of techniques (e.g., arterial inflow, venous capacitance, maximum venous outflow), often with rapid cuff inflation devices. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817065021594	GS1	Pouch	8	In Commercial Distribution
Primary	00817065021204	GS1
Package	00817065021587	GS1	Pouch	8	In Commercial Distribution
Package	00817065021570	GS1	Pouch	7	In Commercial Distribution

Customer Contacts

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