FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709076402
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
46114-35
Catalog number
46114-35
Device description
Umbilical Blood Draw Kit Venous Line w/Needleless Valve
Published
2021-08-29
Public version status
New
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
FJKSet, tubing, blood, with and without anti-regurgitation valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation ValveGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983559000BLOOD TUBING ACCESSORY WITH CLAVE CONNECTORIcu Medical, Inc.1998-12-24FJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709076409PackageGS120In Commercial Distribution
00887709076402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770907640910887709076409
00887709076402008877090764028877090764020887709076402

GMDN Terms#

Term, Definition table
TermDefinition
In-line arterial blood sampling setA collection of sterile devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. It is a haemodynamic pressure monitoring and blood gas sampling device, typically designed for use with disposable/reusable pressure transducers, intended to connect to a central line/arterial catheter from which the blood specimen is obtained. Heparinized blood may be reinfused into the patient via the device to reduce fluid loss. This is a single-patient device that may be used short term (single-use) before being discarded.

Contacts#

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

Regulatory Flags#

DUNS number
118380146
Device count
1
Kit
true
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
10887709206622BivonaZT26JN45NSF109N2026-10-26
10887709206639BivonaZT26JN40NSE108N2026-10-26
10887709206790BivonaZU26JN60NSC128N2026-10-26
10887709206806BivonaST22LN60NSZ210N2026-10-26
10887709207025BivonaSA26JN95ZSC110N2026-10-26
10887709207384BivonaFT26JN35NGA179N2026-10-26
10887709207391BivonaFU26JN35NGA180N2026-10-26
10887709207438BivonaFT26JN50NSA183N2026-10-26
10887709146966LifeShield Infusion Safety Software Suite - DFM17002-032026-10-23
10887709146973LifeShield Infusion Safety Software Suite - DLM17003-032026-10-23
10887709146980LifeShield Infusion Safety Software Suite - CDR17005-032026-10-23
10887709155050LifeShield Infusion Safety Software Suite17000-032026-10-23
10887709207230BivonaFU26JN50NSF167N2026-10-23
10887709207247BivonaFU26JN40NSF171N2026-10-23
10887709207254BivonaFT26JN35NGF170N2026-10-23
10887709207261BivonaFT26JN40NSA166N2026-10-23
10887709207278BivonaFU26JN55NGF168N2026-10-23
10887709207339BivonaFT26JN30NGE178N2026-10-23
10887709207346BivonaFT26JN35NGF174N2026-10-23
10887709207353BivonaFT26JN35NGF175N2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09555793100891VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100907VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100921VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100938VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100945VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100969VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100976VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100983VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100990VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793101003VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107524VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107531VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107548VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107555VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107562VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107579VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107586VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107593VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107609VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
08859915300024N/ATIANYI MEDICAL(THAILAND) LIMITEDFJK2026-08-03
09555793100914VITALVITAL HEALTHCARE SDN. BHD.FJK2026-07-24
09555793100952VITALVITAL HEALTHCARE SDN. BHD.FJK2026-07-24
09555793102284VITALVITAL HEALTHCARE SDN. BHD.FJK2026-07-24
06948082774904NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-06-04
06948082700729DORABain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-05-13
04711552764666SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-24
04711552760026SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552761498SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764048SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764086SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23