FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709061705
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
PCX45D
Catalog number
PCX45D
Device description
TriOx™-PICC Peripherally Inserted Central Venous Oximetry Catheter, 45 cm, Dual Lumen
Published
2021-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQECatheter, oximeter, fiber-optic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQECatheter, Oximeter, Fiber-OpticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140129000PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETERIcu Medical, Inc.2014-07-02DQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709061702PackageGS15In Commercial Distribution
00887709061705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770906170210887709061702
00887709061705008877090617058877090617050887709061705

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary artery balloon catheter, non-electricalA flexible, non-electrical tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein (e.g., jugular, subclavian), and advanced from the superior vena cava to the pulmonary artery, to measure/monitor a haematological parameter(s) [e.g., pulmonary arterial pressures (e.g., wedge), stroke volume] via the pressure changes at its distal tip. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., external blood pressure transducer) and may include devices dedicated to introduction. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(866)829-9025customerservice@icumed.com

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709204192BivonaZT26IS70NSC117N2026-09-25
10887709204451BivonaSZ26IN60NSB136S2026-09-25
10887709204734BivonaSU26IN45NSZ100N2026-09-25
10887709204901BivonaFT26IN60NGF183N2026-09-25
10887709204918BivonaFT26IN35NGA182N2026-09-25
10887709204925BivonaSF26IN80NSC186N2026-09-25
10887709204932BivonaSF26IN80NSC185N2026-09-25
10887709204949BivonaFT26IN35NGE187N2026-09-25
10887709204826BivonaFT26IN35NSA181N2026-09-24
10887709204833BivonaFT26IN40NGE170N2026-09-24
10887709204840BivonaFT26IN45NGF169N2026-09-24
10887709204857BivonaFT26IN40NGE179N2026-09-24
10887709204864BivonaFT26IN40NGF172N2026-09-24
10887709204871BivonaFT26IN55NGF171N2026-09-24
10887709204888BivonaHU26IS40NGE177N2026-09-24
10887709204895BivonaHU26IS45NGF178N2026-09-24
10887709204505BivonaFU26IN40NGF143N2026-09-22
10887709204512BivonaFU26IN35NGF144N2026-09-22
10887709204550BivonaFU26IN60NSF145N2026-09-22
10887709204680BivonaFU26IN55NSA164N2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDQE2026-03-16
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
50690103218621SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103000412SWAN-GANZEdwards Lifesciences LLCDQE2026-01-30
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCDQE2025-09-10
00690103219531Acumen IQ PlusEdwards Lifesciences LLCDQE2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCDQE2025-09-10
00690103219616ForeSight IQEdwards Lifesciences LLCDQE2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCDQE2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCDQE2025-07-11
50690103219611ForeSight IQEdwards Lifesciences LLCDQE2025-07-11
10889483591420Vital Signs™AirLife Finland OyDQE2025-04-02
10889483591437Vital Signs™AirLife Finland OyDQE2025-04-02
00840619046613ICU MedicalICU MEDICAL, INC.DQE2025-03-25
10840619046610ICU MedicalICU MEDICAL, INC.DQE2025-03-25
00690103217957HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
00690103219371SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
00690103219289SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
50690103219376SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
00690103218879HemoSphere VitaEdwards Lifesciences LLCDQE2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCDQE2024-08-28
00690103219388SWAN-GANZEdwards Lifesciences LLCDQE2024-08-05
50690103219383SWAN-GANZEdwards Lifesciences LLCDQE2024-08-05
00690103217124HemoSphere VitaEdwards Lifesciences LLCDQE2024-02-26
00690103218848HemoSphere VitaEdwards Lifesciences LLCDQE2024-02-26