Affiniti 30 Ultrasound System

GUDID 00884838124974

Affiniti 30 Ultrasound System VM 12.0

Philips Ultrasound LLC

General-purpose ultrasound imaging system
Primary Device ID00884838124974
NIH Device Record Key395a15d0-365f-4075-997a-fbbafbd91e23
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffiniti 30 Ultrasound System
Version Model Number795218
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
GS100884838124974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-12-27
Device Publish Date2024-12-19

Devices Manufactured by Philips Ultrasound LLC

00884838124912 - EPIQ Elite Diagnostic Ultrasound System2024-12-27 EPIQ Elite Diagnostic Ultrasound System VM 12.0.
00884838124974 - Affiniti 30 Ultrasound System2024-12-27Affiniti 30 Ultrasound System VM 12.0
00884838124974 - Affiniti 30 Ultrasound System2024-12-27 Affiniti 30 Ultrasound System VM 12.0
00884838124981 - Affiniti 50 Ultrasound System2024-12-27 VM12.0
00884838124998 - Affiniti 70 Ultrasound System2024-12-27 VM12.0
00884838109995 - EPIQ 7C Diagnostic Ultrasound System Circular Edition2024-08-19 VM 11.0 update
00884838100213 - Transducer C5-1 2024-08-07 Introduction of C5-1 (Shanghai Version) to rest of the world.
00884838124233 - TOMTEC ARENA2024-07-11
00884838125674 - Affiniti CVx Diagnostic Ultrasound System Circular Edition2024-06-20 VM 11.0 update

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