LUMIFY SYSTEM BUNDLE

GUDID 00884838098176

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system
Primary Device ID00884838098176
NIH Device Record Key2a450483-e866-4830-b757-5ef43f354874
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUMIFY SYSTEM BUNDLE
Version Model Number795006
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 Batchtrue
Serial Numberfalse
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
GS100884838098176 [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 Date2021-04-05
Device Publish Date2021-03-27

On-Brand Devices [LUMIFY SYSTEM BUNDLE]

00884838085930989605477201
00884838098176795006

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