FDA.reportPublic FDA data

CODAN

Primary DI
10813153020545
Brand
CODAN
Company
CODAN US CORPORATION
Model
A 410
Device description
Universal IV Administration Set with injection site
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
813153020548PackageGS11In Commercial Distribution
10813153020545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
813153020548008131530205488131530205480813153020548
1081315302054510813153020545

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00813153027899CodanBC5312026-02-25
00813153028124FRESENIUS KABIFK20209KE2026-02-05
00813153028131FRESENIUS KABIFK20253KE2026-02-05
00813153028148FRESENIUS KABIFK20257KE2026-02-05
00813153028155FRESENIUS KABIFK20258KE2026-02-05
00813153028179CodanBC22262026-01-21
00813153027882LABEL PRODUCT -CODANBC5332025-08-27
00813153027936LABEL PRODUCT -CODANBC8042 CUST2025-08-27
00813153027967Kabi Access Infusion SetsFK70100K2025-08-27
00813153027981Kabi Access Infusion SetsFK20219KE2025-08-27
00813153028001Kabi Access Infusion SetsFK70110K2025-08-27
00813153028018Kabi Access Infusion SetsFK70111K2025-08-27
00813153028025LABEL PRODUCT -CODANC3092025-08-27
00813153027929LABEL PRODUCT -CODANB6852025-08-27
00813153027875LABEL PRODUCT -CODANBC5322025-08-26
00813153027912LABEL PRODUCT -CODANBC1582025-08-26
00813153027943LABEL PRODUCT -CODANBC2191N2025-08-26
00813153027950LABEL PRODUCT -CODANBC2192N2025-08-26
00813153028049LABEL PRODUCT -CODANBC2193N2025-08-26
00813153028087LABEL PRODUCT -CODANA4872025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810110920207IMed ProductsASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-23
10810110920214IMed ProductsASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-23
10810110920221IMed ProductsASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-23
28699443581373FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-13
28699443583261NeutrArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-13
00850050080367iLet Insulin Infusion KitBeta Bionics, Inc.FPA2026-03-11
10801741239271MiniLocBard Access Systems, Inc.FPA2026-02-26
00850033629439Acta MedicalActa Medical LLCFPA2026-02-26
00850033629583Acta MedicalActa Medical LLCFPA2026-02-26
00850033629590Acta MedicalActa Medical LLCFPA2026-02-26
00813153027899CodanCodan US CorporationFPA2026-02-25
28699443582158NeutrArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-02-16
00813153028124FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028131FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028148FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028155FRESENIUS KABICodan US CorporationFPA2026-02-05
B2125720502Male Luer Slip PlugINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700B2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700G2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700R2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700V2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700W2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700Y2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
00813153028179CodanCodan US CorporationFPA2026-01-21
10801741239189PowerLocBard Access Systems, Inc.FPA2026-01-20
10801741239196MiniLocBard Access Systems, Inc.FPA2026-01-20
10801741239202MiniLocBard Access Systems, Inc.FPA2026-01-20
10817708023418OPTFlowEMED TECHNOLOGIES CORPORATIONFPA2026-01-09
23661657080947NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAPCAIR LGLFPA2026-01-01
2366165708095413,5 CM PE/PVC EXTENSION TUBING WITH 1 NEUTRACLEAR + 1 CLAMP + 1 MOBILE RINGCAIR LGLFPA2026-01-01