FDA.reportPublic FDA data

PiCCO Monitoring Kit

Primary DI
24250094500089
Brand
PiCCO Monitoring Kit
Company
Pulsion Medical Systems SE
Model
PV8115
Published
2017-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K991886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991886000PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.2000-05-11KRB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24250094500089PackageGS125In Commercial Distribution
04250094500085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2425009450008924250094500089
04250094500085042500945000854250094500085

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure transducer setA collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
04250094501525PulsioFlexPC40002017-03-10
04250094500085PiCCO Monitoring KitPV81152017-03-13
04250094500177PiCCO Monitoring KitPV8115CVP2017-03-13
04250094500184PiCCO Monitoring KitPV81032017-03-13
24250094500171PiCCO Monitoring KitPV8115CVP2017-03-13
24250094500188PiCCO Monitoring KitPV81032017-03-13
24250094500638PiCCO CatheterPV2013L07N2016-09-24
24250094500652PiCCO CatheterPV2014L16N2016-09-24

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27325710011601PiCCO catheterMaquet Critical Care ABKRB2026-03-24
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27325710017108PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710011140ITS HousingMaquet Critical Care ABKRB2026-03-24
07325710011607PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017043PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017067PiCCO catheterMaquet Critical Care ABKRB2026-03-24
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07325710017104PiCCO catheterMaquet Critical Care ABKRB2026-03-24
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