Hokanson

Basic Information

• Brand Name: Hokanson
• Primary DI: 00817065021112
• Version / Model: MV10
• Catalog Number: 00387
• 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: 2016-09-22
• Public Version: 4
• Public Version Date: 2020-10-05
• Public Version Status: Update
• Public Device Record Key: 293dda24-c087-4b13-8c38-e2da6a532bcf
• Distribution End Date: 2017-08-31

Device Description

SEGMENTAL CUFF SELECTOR - A pneumatic valve system for interconnecting a cuff inflator to one or multiple blood pressure cuffs. The cuffs can be deflated completely with the valve(s) of the pneumatic valve system, separately from the cuff inflator.

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
62335	Blood pressure cuff multichannel valve unit	A non-powered device intended to interface between a blood pressure cuff inflator and multiple blood pressure cuffs to allow manual channel selection (i.e., allow one or more selected cuffs to be inflated without disconnection of non-selected cuffs). It is typically a small unit with internal valves and control switches, and is intended to be used during a procedure which requires multiple blood pressure cuffs (e.g., a segmental pressure examination).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817065021112	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K842067	000