Hokanson

Basic Information

• Brand Name: Hokanson
• Primary DI: 00817065021259
• Version / Model: E20
• Catalog Number: 00597
• Company Name: D.E.HOKANSON, INC.
• Labeler DUNS: 071829634
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2020-10-05
• Public Version Status: Update
• Public Device Record Key: 0a6b8b32-b385-45e2-b7c6-7018e0b65ee3
• Distribution End Date: 2017-03-31

Device Description

100V - A cuff inflator for rapidly inflating blood pressure cuffs to a preset pressure, and for rapidly deflating blood pressure cuffs. The inflator holds the cuff pressure constant, until the clinician triggers deflation. The pressure is adjustable, and is set by the clinician according to the needs of the specialty vascular study being performed.

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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62279	Blood pressure cuff inflation regulator	A mains-electricity (AC-powered) device intended to interface between an air compressor and a vascular cuff to regulate rapid inflation of the cuff during procedures to assess vascular health (e.g., venous insufficiency, maximum venous outflow, arterial inflow). Intended to be used by a healthcare professional in a clinical setting, it consists of a compact unit with display/controls, pressure regulator, and tubing to connect to the cuff. It is intended to regulate inflation to a preselected target pressure, to maintain that pressure, and subsequently deflate the cuff; it may be intended to be used with a timer for automatically-triggered inflation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817065021259	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905367	000