Hokanson

Basic Information

• Brand Name: Hokanson
• Primary DI: 00817065021334
• Version / Model: MD6
• Catalog Number: 00864
• 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: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: f750ab95-4ead-4d22-b75b-b6a32acf3242

Device Description

DOPPLER; Non-RoHS version - Portable, continuous wave Doppler for peripheral vascular use, with a detachable transducer. The instrument is battery operated and produces an audio signal proportional to the velocity of blood flow. The Doppler signal can be heard on the built-in loudspeaker or with stereo headphones which provide a sense of flow direction. The Doppler can also be used with a chart recorder for recording velocity waveforms.

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
DXK	Echocardiograph	Cardiovascular	870.2330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44311	Noninvasive vascular ultrasound system	An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817065021334	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K901592	000