FDA.reportPublic FDA data

Hokanson

Primary DI
00817065022416
Brand
Hokanson
Company
D.E.HOKANSON, INC.
Model
MD35 Doppler Barrel
Catalog number
01831
Device description
DOPPLER PROBE BARREL - A replacement Doppler sensor only.
Published
2017-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSBPlethysmograph, Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896034000PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEMD. E. Hokanson, Inc.1990-01-18DSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817065022416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817065022416008170650224168170650224160817065022416

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

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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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2026-06-03
04260451441180Osypka MedicalOsypka Medical GmbHDSB2026-04-24
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDSB2026-03-16
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00690103217728HemoSphereEdwards Lifesciences LLCDSB2025-07-11
00690103217957HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DSB2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DSB2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DSB2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DSB2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DSB2025-03-13
00690103218879HemoSphere VitaEdwards Lifesciences LLCDSB2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCDSB2024-08-28
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B719G62Q0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
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