CORE PC WORKSTATION FRU

GUDID 00845225012809

VOLCANO CORPORATION

Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system
Primary Device ID00845225012809
NIH Device Record Key10b1762c-7ef9-4a27-b33d-4795b78294b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCORE PC WORKSTATION FRU
Version Model Number410-3600.08
Company DUNS135179237
Company NameVOLCANO CORPORATION
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
GS100845225012809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

Devices Manufactured by VOLCANO CORPORATION

20845225012681 - SpinVision STERILE EQUIPEMENT COVER2021-10-26
20845225012698 - DIGITAL IVUS STERILE EQUIPEMENT COVER2021-10-26
10845225012707 - R-100 STERILE EQUIPEMENT COVER2021-10-26
00845225012915 - IntraSight Mobile2021-02-03
00845225012847 - FM-PIM2021-01-29
00845225012656 - CORE FM CART2020-06-02
00845225010874 - ComboMap Pressure and Flow System 2020-01-01
00845225002565 - Pioneer Plus Catheter2019-03-21

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