FDA.reportPublic FDA data

Injectate temperature sensor housing

Primary DI
04250094500153
Brand
Injectate temperature sensor housing
Company
Pulsion Medical Systems SE
Model
PV4046
Device description
Injectate temperature sensor housing PV4046
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRBProbe, Thermodilution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRBProbe, ThermodilutionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020587000PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AG2002-05-23KRB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24250094500157PackageGS110In Commercial Distribution
04250094500153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2425009450015724250094500157
04250094500153042500945001534250094500153

GMDN Terms#

Term, Definition table
TermDefinition
Thermal-dilution cardiac output unitA unit that measures the blood flow from the heart using the indicator dilution technique, in which a thermal indicator (e.g., cold saline solution or other indicator solution) is injected upstream of the heart and monitored on the downstream side by a balloon-tipped (flow-directed) catheter with a temperature probe. The measured results are reproduced by this device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+490894599140info@pulsion.com
+490894599140zentrale.pulsion@getinge.com

Regulatory Flags#

DUNS number
316093673
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
04250094500641PiCCO CatheterPV2014L08N2016-09-24
04250094500665PiCCO CatheterPV2014L22N2016-09-24
04250094500931PiCCO CatheterPV2015L20-A2018-04-06
04250094501402PiCCO ModulePC45102017-03-10
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

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27325710017108PiCCO catheterMaquet Critical Care ABKRB2026-03-24
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07325710017067PiCCO catheterMaquet Critical Care ABKRB2026-03-24
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07325710017104PiCCO catheterMaquet Critical Care ABKRB2026-03-24
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