FDA.reportPublic FDA data

Codan

Primary DI
10813153023355
Brand
Codan
Company
Codan US Corporation
Model
BC 2058-TF
Device description
Hi-Flow Extension Set with Swab able Stopcock
Published
2016-09-20
Public version status
Update
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
813153023358PackageGS11In Commercial Distribution
10813153023355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
813153023358008131530233588131530233580813153023358
1081315302335510813153023355

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058027475
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
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

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Primary DI, Brand, Company table
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07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
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