FDA.reportPublic FDA data

PiCCO Catheter

Primary DI
04250094500962
Brand
PiCCO Catheter
Company
Pulsion Medical Systems SE
Model
PV2014L16-A
Device description
4F Thermodilution catheter, 160mm
Published
2018-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K171620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171620000PiCCO CatheterPulsion Medical Systems SE2018-02-21KRB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14250094500969PackageGS15In Commercial Distribution
24250094500966PackageGS110In Commercial Distribution
04250094500962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425009450096914250094500969
2425009450096624250094500966
04250094500962042500945009624250094500962

GMDN Terms#

Term, Definition table
TermDefinition
Thermal dilution peripheral artery catheterA short, thin, flexible tube intended for short-term (<= 30 days) percutaneous placement into a peripheral artery (excluding pulmonary artery) during measurement/monitoring of haematological parameters (e.g., arterial pressure, cardiac output/index) using thermal dilution techniques. It is designed to be used as the downstream sensor during thermal dilution, whereby it is intended to be used in conjunction with a central venous catheter (intended for upstream solution introduction) and an external monitor. It includes an electronic thermistor and may include devices dedicated to introduction/function. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Length160Millimeter

Contacts#

Phone, Email table
PhoneEmail
+49894599140zentrale.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
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
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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