FDA.reportPublic FDA data

ICU Medical

Primary DI
00840619043636
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
41227-02
Catalog number
41227-02
Device description
TD Catheter, 7F, 4 lumen, 110 cm, S-Tip, LF
Published
2021-10-19
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
DYGCATHETER, FLOW DIRECTED
KRBPROBE, THERMODILUTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQECatheter, Oximeter, Fiber-OpticCardiovascular2
DYGCatheter, Flow DirectedCardiovascular2
KRBProbe, ThermodilutionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091268000HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSHospira, Inc.2009-09-18DQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840619043633PackageGS15In Commercial Distribution
00840619043636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061904363310840619043633
00840619043636008406190436368406190436360840619043636

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
10887709194899BivonaFU26FN35NGE024N2026-06-04
10887709194905BivonaFT26FN40NGE027N2026-06-04
10887709194912BivonaFU26FN40NGE028N2026-06-04
10887709194929BivonaXT26FS50NSF019N2026-06-04
10887709194936BivonaFT26EN40NSF122S2026-06-04
10887709194943BivonaFT26EN40NSF122S2026-06-04
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403522270Swan-GanzBecton, Dickinson And CompanyDYG2026-05-30
00885403522348SWAN-GANZ CCOMBO VBecton, Dickinson And CompanyDYG2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDYG2026-05-30
08886483551664Safewedge(TM) Relief Valve DeviceBIOPTIMAL INTERNATIONAL PTE. LTD.KRB2026-05-20
27325710011144ITS HousingMaquet Critical Care ABKRB2026-03-24
27325710011601PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017047PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017061PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017092PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017108PiCCO catheterMaquet Critical Care ABKRB2026-03-24
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDQE2026-03-16
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDYG2026-03-16
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103000412SWAN-GANZEdwards Lifesciences LLCDQE2026-01-30
00690103000078CO-SET INJECTATE ICE BUCKETEdwards Lifesciences LLCKRB2025-07-16
00690103217124HemoSphere VitaEdwards Lifesciences LLCDQE2024-02-26
00690103210927FORESIGHT OXIMETER CABLEEdwards Lifesciences LLCDQE2023-07-28
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyKRB2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyKRB2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyKRB2023-04-19
00195278524089NAGE Healthcare Finland OyKRB2023-04-19
00690103215847Viewfinder remote appEdwards Lifesciences LLCDQE2023-01-13
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10801902206432ARROWTELEFLEX INCORPORATEDDYG2022-10-20
10801902206456ARROWTELEFLEX INCORPORATEDDYG2022-10-20
10801902209372ARROWTELEFLEX INCORPORATEDDYG2022-05-20
10801902208979ARROWTELEFLEX INCORPORATEDDYG2022-03-18
10801902206647ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206654ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206661ARROWTELEFLEX INCORPORATEDDYG2022-03-14