ACIST RXi® Mini System Overpack

GUDID 40841716101586

RXi Mini System, p/n 801075-001 Processing Unit, Navvus Interface, Mounts, and Accessory Box (Power Cord and Cables)

ACIST MEDICAL SYSTEMS, INC.

Cardiac catheterization laboratory computer
Primary Device ID40841716101586
NIH Device Record Key500566f8-fd17-4e6f-82fb-fac546e6feb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameACIST RXi® Mini System Overpack
Version Model Number018599
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 Kittrue
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
GS140841716101586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRQAmplifier And Signal Conditioner, Transducer Signal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-14
Device Publish Date2019-05-06

On-Brand Devices [ACIST RXi® Mini System Overpack]

40841716101753RXi Mini System, p/n 801042-001 Processing Unit, Navvus Interface, Mounts, and Accessory Box (Po
40841716101586RXi Mini System, p/n 801075-001 Processing Unit, Navvus Interface, Mounts, and Accessory Box (P

Trademark Results [ACIST RXi]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACIST RXI
ACIST RXI
86110834 4791283 Live/Registered
ACIST Medical Systems, Inc.
2013-11-05

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