FDA.reportPublic FDA data

NA

Primary DI
00198953066560
Brand
NA
Company
GE Healthcare Finland Oy
Model
PiCCO Injectate Sensor Cable
Device description
PICCO INJECTATE SENSOR CABLE, M1182448
Published
2026-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DXGComputer, Diagnostic, Pre-Programmed, Single-Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132528000E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIESGE Healthcare Finland Oy2014-01-16DXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682103015PreviousGS10
00198953066560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682103015008406821030158406821030150840682103015
00198953066560001989530665601989530665600198953066560

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
401966697
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953009567Carescape ONE259560312026-10-04
00840682106498Mobile CareWeb Viewer2016-06-21
00840682102957EntropyGE Entropy sensor, M10386812016-08-15
00840682102971EntropyEasyFit sensor, M11744132016-08-15
00840682102964EntropyEntropy Cable, M1050784M10507842016-06-30
00840682103015NAPiCCO Injectate Sensor Cable2016-06-10
00840682103039NAPiCCO Continuous Cardiac Output Cable2016-06-16
00840682102841NAD-Lite Spirometry Kit 3m/10ft, 80043822016-08-15
00840682102858NAPedi-Lite Spirometry Kit 3m, M10326342016-08-15
00840682102865NAPedi-lite Spirometry Kit 2m, 80027182016-08-15
00840682102926NAMini D-fend Water Trap, 800217480021742016-08-12
00840682102896NACalibration Gas, 7555872016-06-10
00840682102902NACalibration Gas, 755571-HEL2016-06-10
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00195278697165PORTRAIT HSWXBHSWXB5700219-112024-04-30
00195278466662E-EEGXMJD1012022-07-01
00195278466679N-EEGXMJS1012022-07-01
00195278022639NA5514183 Gas exhaust line, white conical and Colder55141832022-02-09
00195278022646NA5514182 Gas exhaust line, white conical and Colder55141822022-02-09
00195278022653NA5514184 Gas exhaust line, white conical, disposabl55141842022-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403533122ECG Slave Cable for Spaclab PCI and PC2 with PigtailBecton, Dickinson And CompanyDXG2026-09-18
00885403533146TruWave Reusable CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533153ECG Slave Cable for Spaclab PCI and PC2 with PigtailBecton, Dickinson And CompanyDXG2026-09-18
00885403533160TruWave Reusable CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533610TruWave Reusable CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533634Pressure Slave CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533641Cable COO Catheter InterfaceBecton, Dickinson And CompanyDXG2026-09-18
00885403529781ClearSightBecton, Dickinson And CompanyDXG2026-07-29
00885403529798ClearSightBecton, Dickinson And CompanyDXG2026-07-29
00885403529811ClearSightBecton, Dickinson And CompanyDXG2026-07-29
00864609000348VitalStream ART Connect; VitalStream Hemo; ART DockCARETAKER MEDICAL, LLCDXG2026-06-02
00850044487042Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487103Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487110Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487127Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487134Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDXG2026-04-15
00198953049181NAGE Healthcare Finland OyDXG2026-01-05
07290020154101BB-613W Wrist-MonitorBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
07290020154309BB-613 H@H kitBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
00843997001823LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997002882LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017428LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017435LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017190LiDCOMASIMO CORPORATIONDXG2024-07-26
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2024-07-10
00850044487011Retia MedicalRETIA MEDICAL, LLCDXG2024-02-01
17290013030044StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
27290013030041StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12