toc1m neurovision transcranial doppler

Basic Information

• Brand Name: toc1m neurovision transcranial doppler
• Primary DI: 08622630003019
• Version / Model: TOC1M NEUROVISION
• Catalog Number: TOC1M
• Company Name: MULTIGON INDUSTRIES INC
• Labeler DUNS: 144683042
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e97f3443-ef42-4824-aea6-b8487cc0a371

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	892.1550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08622630003019	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K060112	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 27 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 40 – 60 Percent (%) Relative Humidity