CLEARVUE 350 ULTRASOUND SYSTEM

GUDID 00884838097667

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system
Primary Device ID00884838097667
NIH Device Record Key35644645-7f9a-4aa0-ae1d-28dc54c10fb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEARVUE 350 ULTRASOUND SYSTEM
Version Model Number795080
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 Batchtrue
Serial Numberfalse
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
GS100884838097667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-24
Device Publish Date2020-08-14

Devices Manufactured by Philips Ultrasound, Inc.

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00884838123977 - EPIQ CVxi Diagnostic Ultrasound System2024-06-06 VM 11.0 Update
00884838123984 - Affiniti CVx Diagnostic Ultrasound System2024-06-06 VM11.0 update
00884838114265 - Affinti 30 Diagnostic Ultrasound System Circular Edition2024-06-04 VM10.0 Update
00884838114241 - Affinti 50 Diaagnostic Ultrasound System Circular Edition2024-05-13 Software Version 10.0.2
00884838114258 - Affinti 70 Diaagnostic Ultrasound System Circular Edition2024-05-13 Software Version 10.0.2
00884838114203 - EPIQ 7 Diagnostic Ultrasound System Circular Edition2024-04-18 10.0.X Circular Edition

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