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

00884838123625 - Ultrasound System 5500CV2025-07-28 As part of SW 2.0
00884838123632 - Ultrasound System 5500P2025-07-28 Part of SW 2.0
00884838123649 - Ultrasound System 5500W2025-07-28 Part of SW 2.0
00884838123656 - Ultrasound System 5300G2025-07-28 Part of SW 2.0
00884838123663 - Ultrasound System 5300W2025-07-28 As part of SW 2.0
00884838123670 - Ultrasound System 5300P2025-07-28 As part of SW 2.0
00884838123687 - Ultrasound System 5500G2025-07-28 As part of SW 2.0
00884838125964 - Lumify USB-C to USB-C Transducer cable2025-07-22 Lumify USB-C to USB-C Transducer cable

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