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
10813153027339CodanBC21742026-07-31
10813153028312Codan2994.252026-07-31
10813153028329CodanLS2552026-07-17
10813153027384CodanBC10262026-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationFPA2026-06-30
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23