FDA.reportPublic FDA data

ICU Medical

Primary DI
10840619046443
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
41411-23
Catalog number
414110423
Device description
Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 14 cm, PMAP, Expanded Kit
Published
2021-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10840619046443PackageGS15In Commercial Distribution
00840619046446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061904644310840619046443
00840619046446008406190464468406190464460840619046446

GMDN Terms#

Term, Definition table
TermDefinition
Centrally-inserted central venous catheterA flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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10840619046610ICU MedicalICU MEDICAL, INC.DQE2025-03-25
00690103217957HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
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00690103217971HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
00690103219371SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
00690103219289SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
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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