Lumify Rugged System Bundle

GUDID 00884838085947

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system
Primary Device ID00884838085947
NIH Device Record Key771b77f3-40aa-4431-a791-435515675b24
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumify Rugged System Bundle
Version Model Number989605477051
Company DUNS063377717
Company NamePhilips Ultrasound, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100884838085947 [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 Number2
Public Version Date2018-07-06
Device Publish Date2018-05-23

On-Brand Devices [Lumify Rugged System Bundle]

00884838085947989605477051
00884838098183795007
00884838108448795007

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