FDA.reportPublic FDA data

PulsioFlex

Primary DI
04250094501525
Brand
PulsioFlex
Company
Pulsion Medical Systems SE
Model
PC4000
Published
2017-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXGComputer, Diagnostic, Pre-Programmed, Single-Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122121000
K172259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122121000PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULEPulsion Medical Systems SE2012-08-02DXG
K172259000PulsioFlex Monitoring SystemPulsion Medical Systems SE2018-01-18DXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250094501525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250094501525042500945015254250094501525

GMDN Terms#

Term, Definition table
TermDefinition
Invasive arterial pressure cardiac output/oximetry monitorA mains electricity (AC-powered) device, which may have internal rechargeable batteries, designed to continuously measure and display arterial pressure cardiac output (APCO) [minimally-invasive cardiac output estimation from arterial blood pressure waveforms] and haemoglobin oxygen saturation (e.g., SpO2) when connected to an extravascular blood pressure transducer linked to a peripheral arterial line, and to a pulse oximeter or an oximetry catheter. It is typically used in the operating room or intensive care unit (ICU) and may also calculate other haemodynamic parameters including cardiac index, stroke volume, and/or systemic vascular resistance.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49894599140info@pulsion.com
+49894599140zentrale.pulsion@getinge.com

Regulatory Flags#

DUNS number
316093673
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250094500634PiCCO CatheterPV2013L07N2016-09-24
04250094500658PiCCO CatheterPV2014L16N2016-09-24
04250094500672PiCCO CatheterPV2015L20N2016-09-24
04250094500948PiCCO CatheterPV2013L07-A2018-04-11
04250094500955PiCCO CatheterPV2014L08-A2018-04-11
04250094500962PiCCO CatheterPV2014L16-A2018-04-12
04250094500979PiCCO CatheterPV2014L22-A2018-04-12
04250094500153Injectate temperature sensor housingPV40462016-09-29
04250094500641PiCCO CatheterPV2014L08N2016-09-24
04250094500665PiCCO CatheterPV2014L22N2016-09-24
04250094500931PiCCO CatheterPV2015L20-A2018-04-06
04250094501402PiCCO ModulePC45102017-03-10
04250094500085PiCCO Monitoring KitPV81152017-03-13
04250094500177PiCCO Monitoring KitPV8115CVP2017-03-13
04250094500184PiCCO Monitoring KitPV81032017-03-13
24250094500089PiCCO Monitoring KitPV81152017-03-13
24250094500171PiCCO Monitoring KitPV8115CVP2017-03-13
24250094500188PiCCO Monitoring KitPV81032017-03-13
24250094500638PiCCO CatheterPV2013L07N2016-09-24
24250094500652PiCCO CatheterPV2014L16N2016-09-24

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Primary DI, Brand, Company table
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00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDXG2026-04-15
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07290020154101BB-613W Wrist-MonitorBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
07290020154309BB-613 H@H kitBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
00843997001823LiDCOMASIMO CORPORATIONDXG2024-07-26
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09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2024-07-10
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00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDXG2023-04-19
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00850044487004Retia MedicalRETIA MEDICAL, LLCDXG2023-02-21
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2022-06-09