FDA.reportPublic FDA data

Hokanson

Primary DI
00817065021242
Brand
Hokanson
Company
D.E.HOKANSON, INC.
Model
E20
Catalog number
00602
Device description
110V OR 220V - 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.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905367000E-20 RAPID CUFF INFLATORD. E. Hokanson, Inc.1991-03-06DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817065021242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817065021242008170650212428170650212420817065021242

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff inflation regulatorA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-999-8251info@deh-inc.com
425-882-1689info@deh-inc.com

Regulatory Flags#

DUNS number
071829634
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817065020153Hokanson03845038452026-03-27
00817065022614Hokanson03844038442026-03-27
00817065022621Hokanson03843038432026-03-27
00817065022638Hokanson03842038422026-03-27
00817065022645Hokanson03841038412026-03-27
00817065022652Hokanson03840038402026-03-27
00817065020849Hokanson03759037592016-09-09
00817065022348HokansonDP2.5™431012017-07-18
00817065022607Hokanson03027030272021-10-14
00817065022584Hokanson43305433052021-09-16
00817065022591Hokanson43306433062021-09-16
00817065022522Hokanson43660436602020-04-27
00817065022539Hokanson43662436622020-04-27
00817065022546Hokanson43664436642020-04-27
00817065022553Hokanson43666436662020-04-27
00817065022560Hokanson43668436682020-04-27
00817065022508HokansonDP2.0™037382019-06-14
00817065020061Hokanson03602036022016-09-09
00817065020085Hokanson03079030792016-09-09
00817065020139Hokanson03686036862016-09-09

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Primary DI, Brand, Company table
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