FDA.reportPublic FDA data

Hokanson

Primary DI
00817065021594
Brand
Hokanson
Company
D.E.HOKANSON, INC.
Model
Indium Gallium Strain Gauge
Catalog number
03355
Device description
A plethysmograph sensor that attaches to a plethysmograph instrument, used to measure volume changes in a limb or digit. The sensor has a tube filled with electrically resistive fluid (indium-gallium), and is wrapped around the circumference of the limb or digit. The plethysmograph instrument measures the resistance changes of the sensor that occur when the resistive fluid column length changes according to circumference changes that occur with vascular flow changes.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPTProbe, Blood-Flow, Extravascular
JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPTProbe, Blood-Flow, ExtravascularCardiovascular2
JOMPlethysmograph, Photoelectric, Pneumatic Or HydraulicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817065021570PackageGS17In Commercial Distribution
00817065021587PackageGS18In Commercial Distribution
00817065021594PackageGS18In Commercial Distribution
00817065021204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817065021570008170650215708170650215700817065021570
00817065021587008170650215878170650215870817065021587
00817065021594008170650215948170650215940817065021594
00817065021204008170650212048170650212040817065021204

GMDN Terms#

Term, Definition table
TermDefinition
Limb plethysmograph strain transducerA non-sterile, hoop-like device intended to be wrapped around a limb or digit and used in conjunction with a limb plethysmograph (not included) to determine volume variations in the extremities (e.g., legs, toes, arms, fingers) as modified by the circulation of blood through them. Often referred to as a strain gauge, it typically operates based on electrical resistance changes with length, and is used during assessment of a variety of clinical conditions (e.g., endothelial dysfunction, reactive hyperemia, deep vein thrombosis) and for a number of techniques (e.g., arterial inflow, venous capacitance, maximum venous outflow), often with rapid cuff inflation devices. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
071829634
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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