FDA.reportPublic FDA data

PiCCO Module

Primary DI
04250094501402
Brand
PiCCO Module
Company
Pulsion Medical Systems SE
Model
PC4510
Published
2017-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04250094501402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250094501402042500945014024250094501402

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, cardiac outputA small unit dedicated to the measurement of cardiac output (the volume of blood pumped by the heart per minute) obtained through a pressure transducer/catheter introduced into a blood vessel. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the cardiac output parameter/information measured and provided by this module.

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
04250094501525PulsioFlexPC40002017-03-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850044487103Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487110Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487127Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487134Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDXG2026-04-15
00198953049181NAGE Healthcare Finland OyDXG2026-01-05
00198953066560NAGE Healthcare Finland OyDXG2026-01-05
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
00843997002882LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017428LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017435LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017190LiDCOMASIMO CORPORATIONDXG2024-07-26
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2024-07-10
00850044487011Retia MedicalRETIA MEDICAL, LLCDXG2024-02-01
17290013030044StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
27290013030041StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
47290013030045StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
07290013030047StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
77290013030046StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDXG2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDXG2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDXG2023-04-19
00195278524089NAGE Healthcare Finland OyDXG2023-04-19
00850044487004Retia MedicalRETIA MEDICAL, LLCDXG2023-02-21
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2022-06-09