ACIST HDi® System Console

GUDID 10841716102148

HDi System Console, p/n 701460-006

ACIST MEDICAL SYSTEMS, INC.

Cardiovascular ultrasound imaging system
Primary Device ID10841716102148
NIH Device Record Key2805a6df-9719-46f0-b33d-1c70619757a0
Commercial Distribution Discontinuation2020-01-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameACIST HDi® System Console
Version Model Number017987
Company DUNS926684994
Company NameACIST MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
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
GS110841716102148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBJCatheter, Ultrasound, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-05-09
Device Publish Date2019-01-04

On-Brand Devices [ACIST HDi® System Console]

10841716102148HDi System Console, p/n 701460-006
10841716101851HDi System Console, p/n 701460-005
30841716100254HDi System Console, p/n 701460-004

Trademark Results [ACIST HDi]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACIST HDI
ACIST HDI
86110839 4898988 Live/Registered
ACIST Medical Systems, Inc.
2013-11-05

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