FDA.reportPublic FDA data

CHR. HANSEN

Primary DI
10813153024598
Brand
CHR. HANSEN
Company
Codan US Corporation
Model
CH 610 422
Device description
"84"" Transfer Set with Large Bore Tubing"
Published
2017-04-30
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
00813153024591PackageGS11In Commercial Distribution
10813153024598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813153024591008131530245918131530245910813153024591
1081315302459810813153024598

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous fluid bag spikeA small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.

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
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
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
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