FDA.reportPublic FDA data

PULSION MEDICAL SYSTEMS SE

Matched from indexed company URL: Pulsion Medical Systems SE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30032630923003263092PULSION MEDICAL SYSTEMS SE1N2026-01-01Hans-Riedl-Strasse 17 Feldkirchen Bavaria DE 85622

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04250094500153Injectate temperature sensor housing - Injectate temperature sensor housing PV4046+490894599140info@pulsion.com
04250094500153Injectate temperature sensor housing - Injectate temperature sensor housing PV4046+490894599140zentrale.pulsion@getinge.com
04250094500634PiCCO Catheter - 3F Thermodilution catheter, 7cm+490894599140zentrale.pulsion@getinge.com
04250094500658PiCCO Catheter - 4F Thermodilution catheter, 16cm+490894599140zentrale.pulsion@getinge.com
04250094500672PiCCO Catheter - 5F Thermodilution catheter, 20cm+490894599140zentrale.pulsion@getinge.com
04250094500948PiCCO Catheter - 3F Thermodilution catheter, 70mm+49894599140zentrale.pulsion@getinge.com
04250094500955PiCCO Catheter - 4F Thermodilution catheter, 80mm+49894599140zentrale.pulsion@getinge.com
04250094500962PiCCO Catheter - 4F Thermodilution catheter, 160mm+49894599140zentrale.pulsion@getinge.com
04250094500979PiCCO Catheter - 4F Thermodilution catheter, 220mm+49894599140zentrale.pulsion@getinge.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
182211664834788K991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORKRB2000-05-11
182211933247777K780126DILATOR, VESSEL & INTRODUCER, SHEATHDRE1978-03-02
182211078363694K172259PulsioFlex Monitoring SystemDXG2018-01-18
182211639887274K171620PiCCO CatheterKRB2018-02-21
182211961722713K122121PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULEDXG2012-08-02
182211245309833K112448PULSIOFLEXDXG2011-09-22
182211134192150K091786PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)DXG2010-06-18
182211259448733K072735PULSION PICCO-2, MODEL 8500DXG2007-10-18
182211377177401K072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESKRB2007-09-19
182211511943431K060898PULSION PICCO PLUS, MODEL 8100DXG2006-07-25
182211578102301K020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046KRB2002-05-23
182211677424840K001762PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEMDXG2000-06-13
182211423583115
182211621572776

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXG72018-01-18
KRB52018-02-21
DRE11978-03-02

PMN#

GUDID#