Affiniti 50 Ultrasound System

GUDID 00884838106604

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system
Primary Device ID00884838106604
NIH Device Record Key324f533d-0e61-408f-8826-c14a4e225594
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffiniti 50 Ultrasound System
Version Model Number795208
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838106604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-29
Device Publish Date2021-09-21

On-Brand Devices [Affiniti 50 Ultrasound System]

00884838097759795208
00884838106604795208

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