FDA.reportPublic FDA data

Philips Hemodynamic Application

Primary DI
00884838084544
Brand
Philips Hemodynamic Application
Company
Philips Medical Systems Nederland B.V.
Model
Philips Hemodynamic Application - 1
Catalog number
002010
Device description
Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment.
Published
2018-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181311000Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.2018-09-07MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838084544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838084544008848380845448848380845440884838084544

GMDN Terms#

Term, Definition table
TermDefinition
Haemodynamic monitoring system application softwareAn application software program intended to be used as part of a haemodynamic monitoring system to continuously collect, display, and record real-time cardiovascular physiology data [e.g., haemodynamic parameters, electrocardiogram (ECG), SpO2] to monitor a patient during cardiovascular catheterization procedures. It is not intended for bedside monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413819707
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838123786Multimodality Simulation Workspace (MM Sim)1.0Multimodality Simulation Workspace (MM Sim)1.07283492026-06-07
00884838123793Multimodality Simulation Workspace (MM Sim)1.0 UpgradeMultimodality Simulation Workspace (MM Sim)1.0 Upg7283512026-06-07
00884838123748Spectral CT VeridaSpectral CT Verida7283452026-05-26
00884838126398Spectral CT Verida RTSpectral CT Verida RT7283572026-05-26
00884838127555Upgrade Spectral CT VeridaUpgrade Spectral CT Verida7283562026-05-26
00884838127562Upgrade Spectral CT Verida RTUpgrade Spectral CT Verida RT7283722026-05-26
00884838127876Upgrade Spectral CT 7500 SW5.4Upgrade Spectral CT 7500 SW5.47283752026-05-26
00884838127883Upgrades Spectral CT 7500 RT SW5.4Upgrades Spectral CT 7500 RT SW5.47283552026-05-26
00884838128187IngeniaBlueSeal SE7822132026-04-07
00884838128194IngeniaBlueSeal XE7822142026-04-07
00884838128200IngeniaIngenia Elition S7822162026-04-07
00884838128217IngeniaIngenia Elition X7822172026-04-07
00884838128224MR 7700MR 77007822182026-04-07
00884838128231IngeniaUpgrades dStream to R137822192026-04-07
00884838128248IngeniaEvolution Upgrade 1.5T7822202026-04-07
00884838128255IngeniaEvolution Upgrade 3.0T7822212026-04-07
00884838128262IngeniaSmartPath to Ingenia Elition X7822222026-04-07
00884838128293MR 7700Upgrade to MR 77007822252026-04-07
00884838128309MR 7700SmartPath to MR 77007822262026-04-07
00884838128316IngeniaBlueSeal QE7822152026-04-07

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