FDA.reportPublic FDA data

Fenwal Y-Type Blood Comp. Recipient Set with Std. Blood Filter and Luer Adapter

Primary DI
04052682004193
Brand
Fenwal Y-Type Blood Comp. Recipient Set with Std. Blood Filter and Luer Adapter
Company
Fresenius Kabi AG
Model
4C2161
Catalog number
4C2161
Device description
Y-Type Blood Component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Fluid Path
Published
2018-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BRZSet, Blood Transfusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRZSet, Blood TransfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073339000BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORFenwal, Inc.2008-03-03BRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14052682004190PackageGS148In Commercial Distribution
04052682004193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405268200419014052682004190
04052682004193040526820041934052682004193

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion set, non-exchangeAn intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-933-6925xx@xx.xx

Regulatory Flags#

DUNS number
315654579
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811505030573IvenixSET-0040-1SET-0040-12026-06-02
00811137013104Amicus Separator6R4590R6R4590R2026-03-11
00810020442229Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
01081002044222Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
04086000860888COMPOGUARD Advance Basic902974190297412024-10-30
04086000860895COMPOGUARD Advance Data902975190297512024-10-29
04086000860901COMPOGUARD Advance COMPLETE902976190297612024-10-29
04086000860741CompoGuard Basic (NA)902964190296412022-11-10
04086000860758CompoGuard Data (NA)902965190296512022-11-10
04086000860765CompoGuard Complete (NA)902966190296612022-11-10
04086000100199ALYX 2RBC LR KITX4R5720X4R57202018-02-14
04086000100991Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed4R23674R23672016-09-09
04086000100984Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed4R23654R23652016-09-09
00810020440164AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2353G4R2353G2020-10-20
04086000101370Fenwal AMICUS Single Needle Advanced Kit4R23534R23532016-09-02
04086000101387Fenwal AMICUS Double Needle Advanced Kit4R23544R23542016-09-02
00810020440140AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2354G4R2354G2020-10-20
04086000101332Fenwal AMICUS Apheresis Kit - Double Needle4R23554R23552016-09-09
04086000101349Fenwal AMICUS Apheresis Kit - Single Needle4R23574R23572016-09-09
04086000100090AMICUS Apheresis Kit – Single NeedleX6R2312X6R23122025-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68980801R120Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2026-05-04
M68980801R110Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2025-03-04
M68980875100Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2025-02-09
M68980801R100Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2024-12-16
M68980875090Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2022-11-04
M68980801R080Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2022-09-30
M68980801R070Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2022-09-27
M68980875080Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2022-08-23
00085412653303EXTENSION SETBAXTER HEALTHCARE CORPORATIONBRZ2021-12-23
50085412653308EXTENSION SETBAXTER HEALTHCARE CORPORATIONBRZ2021-12-23
M68980801R060Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2021-10-02
M68980875070Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2021-07-28
M68980875030Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2020-03-12
M68980875D030Low Titer Type O Donor Collection SetSafeguard US Operating, LLCBRZ2020-03-12
03660812118484VYGONVYGONBRZ2020-01-29
53660812118489VYGONVYGONBRZ2020-01-29
03660812106122VYGONVYGONBRZ2019-06-26
53660812106127VYGONVYGONBRZ2019-06-26
M69880875020Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2018-09-18
M68980875D020Low Titer Type O Donor Collection SetSafeguard US Operating, LLCBRZ2018-09-18
M68980875010Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2018-05-04
M68980875D010Low Titer Type O Donor Collection SetSafeguard US Operating, LLCBRZ2018-05-04
M68980801R030Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2018-05-04
04052682004148Fenwal Blood Comp. Recipient Set with Std. Blood Filter with Luer AdapterFresenius Kabi AGBRZ2018-03-26
14052682004145Fenwal Blood Comp. Recipient Set with Std. Blood FFresenius Kabi AGBRZ2018-03-26
14052682004190Fenwal Y-Type Blood Comp. Recipient Set with Std. Fresenius Kabi AGBRZ2018-03-26
M68980801R020Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2017-08-04
M68980801R01Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2017-01-23
00085412002408INTERLINKBAXTER INTERNATIONAL INC.BRZ2016-09-24
00085412004006INTERLINKBAXTER INTERNATIONAL INC.BRZ2016-09-24