DEVICE: Hokanson (00817065022577)

Device Identifier (DI) Information

Hokanson
MD35
In Commercial Distribution
00498
D.E.HOKANSON, INC.
00817065022577
GS1

1
071829634 *Terms of Use
DOPPLER AND PLETHYSMOGRAPH SYSTEM - The line-powered instrument contains a direction-sensing continuous wave Doppler, a photo plethysmograph, and a pneumo plethysmograph. Several types of diagnostic tests can be performed allowing the user to choose the most appropriate one for the particular study of interest. A built-in two speed chart recorder can record the waveform from the selected instrument mode. A digital output is included so waveforms can also be captured in computer software.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
13056 Limb plethysmograph
A graphic recorder designed for determining and registering volume variations in the extremities (legs/toes and/or arms/fingers) as modified by the circulation of blood through them. It typically consists of flow and/or volume sensors and transducers attached to an electronic unit, which processes the data and displays the results. It may operate using one of several methods including venous occlusion (pneumatic), photoelectric, electrical impedance, or strain gauge. The device is typically used in peripheral vascular diagnostic investigations [e.g., for deep vein thrombosis (DVT) or arterial occlusive disease].
Active false
34937 Paper chart recorder
A mains electricity (AC-powered) electronic device, which may include internal rechargeable batteries, intended to receive an input signal (e.g., from a physiological amplifier, signal conditioner, computer) which it converts and transcribes onto paper so that the information is stored in the form of a permanent document (hard copy). It will typically include a paper chart driven at constant speed by a motor and a pen(s) that moves back and forth in response to the signal, a printing array (e.g., thermal or electrostatic), or another device for printing on paper. It may be stationary or portable and will typically be used in the absence of a built-in chart recorder.
Active false
61422 Noninvasive vascular ultrasound system, line-powered
A mains electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis), ankle pressure index, and/or blood flow wave form recording.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DSB Plethysmograph, Impedance
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K896034 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

e1265681-bb9b-4679-9bad-0976801b2381
October 01, 2020
1
September 23, 2020
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
800-999-8251
info@deh-inc.com
425-882-1689
info@deh-inc.com
CLOSE