Affiniti CVx Diagnostic Ultrasound System Circular Edition

GUDID 00884838126947

Affiniti CVx Diagnostic Ultrasound System Circular Edition

Philips Ultrasound LLC

General-purpose ultrasound imaging system
Primary Device ID00884838126947
NIH Device Record Keyb4fc863f-32b5-44d2-8e4b-2b250938023e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffiniti CVx Diagnostic Ultrasound System Circular Edition
Version Model Number795407
Company DUNS063377717
Company NamePhilips Ultrasound LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS100884838126947 [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 Date2025-07-01
Device Publish Date2025-06-23

On-Brand Devices [Affiniti CVx Diagnostic Ultrasound System Circular Edition]

00884838125674VM 11.0 update
00884838126947Affiniti CVx Diagnostic Ultrasound System Circular Edition

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