FDA.reportPublic FDA data

ICU Medical

Primary DI
00840619044053
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
41251-06
Catalog number
412510406
Device description
TD Torque-Line Catheter, 7F, 4 Lumen, 110 cm, S-Tip, LF
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
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
10840619044050PackageGS15In Commercial Distribution
00840619044053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061904405010840619044050
00840619044053008406190440538406190440530840619044053

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary artery balloon catheter, electricalA flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measure/monitor haematological parameters [e.g., pulmonary arterial pressures (e.g., wedge), cardiac output, cardiac index, mixed venous oxygen saturation (SvO2)]; it might use thermal dilution techniques and in addition be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included]. 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
10887709206172BivonaFU26JN30NSF074N2026-10-12
10887709206189BivonaFU26JN35NSF073N2026-10-12
10887709206196BivonaFT26JN40NGF076N2026-10-12
10887709206202BivonaST26JN55NSC078N2026-10-12
10887709206219BivonaHA26JS60NSB077N2026-10-12
10887709206226BivonaFT26JN60NSC079N2026-10-12
10887709206233BivonaFU26JN35NSF072N2026-10-12
10887709206240BivonaHT26JS70NSC080N2026-10-12
10887709206257BivonaFT26JN35NSE084N2026-10-12
10887709206264BivonaFT26JN55NGF081N2026-10-12
10887709206271BivonaFT26JN40NGF082N2026-10-12
10887709206288BivonaFT26JN60NGC083N2026-10-12
10887709206103BivonaFU26JN40NGE065N2026-10-09
10887709206110BivonaFT26JN50NGF066N2026-10-09
10887709206127BivonaSU26JN50NSC067N2026-10-09
10887709206134BivonaHU26JS60NSC069N2026-10-09
10887709206141BivonaHU26JS70NSC068N2026-10-09
10887709206158BivonaFU26JN45NSA070N2026-10-09
10887709206165BivonaFT26JN35NSE071N2026-10-09
10887709206011BivonaXU26JS35NGF064N2026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885403523451HemoSphere AltaBecton, Dickinson And CompanyDQE2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyDQE2026-08-06
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
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00690103219616ForeSight IQEdwards Lifesciences LLCDQE2025-07-11
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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