FDA.reportPublic FDA data

toc1m neurovision transcranial doppler

Primary DI
08622630003019
Brand
toc1m neurovision transcranial doppler
Company
MULTIGON INDUSTRIES INC
Model
TOC1M NEUROVISION
Catalog number
TOC1M
Device description
An 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/Dopple. Clinical applications include venous/arteria/cardiovascular/cephalic flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis),emboli counting,vasospasm,sah,, and/or blood flow wave form recording.
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060112000NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEMNodecrest, LLC2006-05-05IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08622630003019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08622630003019086226300030198622630003019

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, line-poweredA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method
Liquid Chemical

Contacts#

Phone, Email table
PhoneEmail
914 376 5200TCDINFO@MULTIGON.COM

Regulatory Flags#

DUNS number
144683042
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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