HeartNavigator 001001

GUDID 00884838059207

Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques.

Philips Medical Systems Nederland B.V.

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Primary Device ID00884838059207
NIH Device Record Key998f9b67-876d-482c-81e5-383457242da6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartNavigator
Version Model NumberHeartNavigator R2
Catalog Number001001
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
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
GS100884838059207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-24
Device Publish Date2016-09-24

On-Brand Devices [HeartNavigator]

00884838080744Software medical device, used with a Philips Interventional X-Ray System. Assists the user with
00884838059207Software medical device, used with a Philips Interventional X-Ray System. Assists the user with

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