Hokanson

Basic Information

• Brand Name: Hokanson
• Primary DI: 00817065022478
• Version / Model: PPG sensor 5-Pin
• Catalog Number: 01833
• Company Name: D.E.HOKANSON, INC.
• Labeler DUNS: 071829634
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-01
• Public Version: 4
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 5601257a-ef4d-43cf-9d3e-248b287ac75d

Device Description

PHOTOTRANSDUCER; 5 PIN CONNECTOR - A plethysmograph sensor that attaches to an electronic plethysmograph instrument, used to measure volume changes due to blood flow changes in a limb or digit. The plethysmograph instrument measures the signal to determine changes in blood volume in the tissue under the sensor.

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
JEH	Plethysmograph, Volume	Anesthesiology	868.1760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62331	Plethysmography phototransducer	A photoelectric sensor designed to be applied externally to a body area (e.g., limb, fingertip, toe, sacral region) for the transcutaneous measurement of blood volume changes using light detection. It is intended to be connected to a parent device (e.g., limb plethysmograph, pressure ulcer risk assessment analyser) whereby volume changes are displayed graphically to represent blood flow/pulse, typically for vascular function assessment in a limb [e.g., measurement of toe brachial pressure index], or to assess a patient’s risk of developing pressure ulcers. Although similar to a pulse oximeter probe it is not capable of oxygen saturation measurements. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817065022478	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K932812	000