FDA.reportPublic FDA data

Kabi Access Infusion Sets

Primary DI
10813153028008
Brand
Kabi Access Infusion Sets
Company
Codan US Corporation
Model
FK70110K
Device description
Manifold2 Port 4-way stopcocks and rotating male Luer-lock
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813153028001PackageGS11In Commercial Distribution
10813153028008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813153028001008131530280018131530280010813153028001
1081315302800810813153028008

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line stopcockA sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.

Regulatory Flags#

DUNS number
058027475
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10813153027322CodanBC 20732026-04-22
10813153028237CodanBC21152026-04-21
10813153028220CodanLS5742026-03-25
10813153027896CodanBC5312026-02-25
00813153027899CodanBC5312026-02-25
10813153028121FRESENIUS KABIFK20209KE2026-02-05
10813153028138FRESENIUS KABIFK20253KE2026-02-05
10813153028145FRESENIUS KABIFK20257KE2026-02-05
10813153028152FRESENIUS KABIFK20258KE2026-02-05
00813153028124FRESENIUS KABIFK20209KE2026-02-05
00813153028131FRESENIUS KABIFK20253KE2026-02-05
00813153028148FRESENIUS KABIFK20257KE2026-02-05
00813153028155FRESENIUS KABIFK20258KE2026-02-05
10813153028176CodanBC22262026-01-21
00813153028179CodanBC22262026-01-21
10813153026950LABEL PRODUCT-CODANBC 21772025-10-30
10813153027971Kabi Access Infusion SetsFK70115K2025-10-23
10813153028107CodanBC21952025-10-22
10813153028114CodanBC20802025-10-22
10813153027308CodanBC 20032025-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624601253Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921207Q2 Blood Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921214Q2 Blood Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921238Q2 Blood Administration SetsQUEST MEDICAL INCFPA2022-12-06
00634624921122High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFPA2022-12-06
00634624921115High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFPA2022-12-05
00634624911062Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-10-26
00634624921382Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921399Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921405Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921412Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921429Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921436Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921016Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921023Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921030Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921061Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921078Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624922044Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24