EPIQ CVx Diagnostic Ultrasound System

GUDID 00884838114135

Software version 10.0.X

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system
Primary Device ID00884838114135
NIH Device Record Key85167407-b469-4753-b421-a7128dbad9a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPIQ CVx Diagnostic Ultrasound System
Version Model Number795231
Company DUNS063377717
Company NamePhilips Ultrasound, 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 Datefalse
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
GS100884838114135 [Primary]

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-12
Device Publish Date2023-05-04

On-Brand Devices [EPIQ CVx Diagnostic Ultrasound System]

00884838114135Software version 10.0.X
00884838123960VM11.0 Update

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