Injectate temperature sensor housing

GUDID 04250094500153

Injectate temperature sensor housing PV4046

Pulsion Medical Systems SE

Thermal-dilution cardiac output unit
Primary Device ID04250094500153
NIH Device Record Keycbd27168-8107-4cd1-a840-90bc0220ac6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameInjectate temperature sensor housing
Version Model NumberPV4046
Company DUNS316093673
Company NamePulsion Medical Systems SE
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+490894599140
Emailinfo@pulsion.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com
Phone+490894599140
Emailzentrale.pulsion@getinge.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104250094500153 [Primary]
GS124250094500157 [Package]
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRBProbe, Thermodilution

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-29

Devices Manufactured by Pulsion Medical Systems SE

24250094500089 - PiCCO Monitoring Kit2019-01-23
24250094500171 - PiCCO Monitoring Kit2019-01-23
24250094500188 - PiCCO Monitoring Kit2019-01-23
04250094500153 - Injectate temperature sensor housing2018-07-06Injectate temperature sensor housing PV4046
04250094500153 - Injectate temperature sensor housing2018-07-06 Injectate temperature sensor housing PV4046
24250094500638 - PiCCO Catheter2018-07-06 3F Thermodilution catheter, 7cm
04250094500641 - PiCCO Catheter2018-07-06 4F Thermodilution catheter, 8cm
24250094500652 - PiCCO Catheter2018-07-06 4F Thermodilution catheter, 16cm
04250094500665 - PiCCO Catheter2018-07-06 4F Thermodilution catheter, 22cm

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