ACIST CVi® Contrast Delivery System

GUDID 40841716102194

CVi Injector p/n 801091-001 Contents: CVi Injector Head, Bed Mount, & Power Supply

ACIST MEDICAL SYSTEMS, INC.

Angiography contrast medium injection system, line-powered, mobile
Primary Device ID40841716102194
NIH Device Record Key5b9b435f-b594-47a8-a39c-73290a1b157d
Commercial Distribution StatusIn Commercial Distribution
Brand NameACIST CVi® Contrast Delivery System
Version Model Number016612
Company DUNS926684994
Company NameACIST MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS140841716102194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXTInjector And Syringe, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-25
Device Publish Date2019-10-17

On-Brand Devices [ACIST CVi® Contrast Delivery System]

40841716101883CVi Injector p/n 800620-024 Contents: CVi Injector Head (Siemens), Control Panel, & Power Supply
40841716101876CVi Injector p/n 800620-023 Contents: CVi Injector Head, Control Panel, & Power Supply
40841716102194CVi Injector p/n 801091-001 Contents: CVi Injector Head, Bed Mount, & Power Supply

Trademark Results [ACIST CVi]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACIST CVI
ACIST CVI
88404234 not registered Live/Pending
Acist Medical Systems, Inc.
2019-04-26

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