Affiniti 50 Diagnostic Ultrasound System

GUDID 00884838056244

Affiniti 50 Diagnostic Ultrasound System

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system
Primary Device ID00884838056244
NIH Device Record Key520e6285-1df8-4db5-84e3-2c155faee5ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffiniti 50 Diagnostic Ultrasound System
Version Model Number989605410251
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838056244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-12
Device Publish Date2016-03-31

On-Brand Devices [Affiniti 50 Diagnostic Ultrasound System]

00884838056244Affiniti 50 Diagnostic Ultrasound System
00884838114173Software version - 10.0.X

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