Hokanson

Basic Information

• Brand Name: Hokanson
• Primary DI: 00817065022430
• Version / Model: TD312RF
• Catalog Number: 00937
• Company Name: D.E.HOKANSON, INC.
• Labeler DUNS: 071829634
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-31
• Public Version: 4
• Public Version Date: 2020-10-05
• Public Version Status: Update
• Public Device Record Key: 26cc72ec-fdef-4a89-b293-5c803a88ea61

Device Description

Calculating Cuff Inflator-Wireless Version - A portable cuff inflator with an electronic memory and calculator used to measure segmental limb systolic pressures and calculate pressure indices. Inflation and deflation are controlled by the clinician. Measured pressure readings can be stored in memory registers of the device, or sent directly to a computer. The instrument is powered by rechargeable batteries.

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: Yes
• 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
62341	Blood pressure cuff inflator, electronic	A hand-held, battery-powered device intended to be used by a healthcare professional in a clinical setting to enable manually-controlled powered inflation of a blood pressure cuff; it may also be intended to store pressure values. It consists of a compact unit with an electronic pump, internal pressure sensor, pressure display, controls, and tubing to connect to the cuff; the cuff is not included. It is intended to be used with a separate blood flow sensor (e.g., Doppler ultrasound or plethysmograph), to allow measurement of blood pressure; it is not intended for rapid cuff inflation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817065022430	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K842067	000