FDA.reportPublic FDA data

NA

Primary DI
00811137010400
Brand
NA
Company
FENWAL, INC.
Model
4C2161
Catalog number
4C2161
Device description
Y-Type Blood component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Fluid Path
Published
2016-09-12
Public version status
Update
Distribution status
Not 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
10811137010407PackageGS148Not in Commercial Distribution
00811137010400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081113701040710811137010407
00811137010400008111370104008111370104000811137010400

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
794519020
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811137010462NA4C23004C23002016-09-12
00811137010769NA4R24224R24222016-09-12
10811137010490Transfer Pack4R20324R20322016-09-12
10811137010612Transfer Pack4R20014R20012016-09-12
10811137010629Transfer Pack4R20044R20042016-09-12
00811137010486Leukoconnect4C43004C43002016-09-12
20811137010626Transfer Pack4R20044R20042016-09-12
10811137010544Transfer Pack4R20144R20142016-09-12
10811137010551Transfer Pack4R20244R20242016-09-12
10811137010636Transfer Pack4R20234R20232016-09-12
00811137010738Transfer Pack4R20274R20272016-09-12
20811137010497Transfer Pack4R20324R20322016-09-12
20811137010619Transfer Pack4R20014R20012016-09-12
00811137012916ALYX Plasma Kit4R57304R57302016-09-08
00811137010431NA4C45024C45022016-09-12
00811137010455NA4C21604C21602016-09-12
00811137010691NA4C22234C22232016-09-12
00811137010714NA4C24684C24682016-09-12
00811137012411Apheresis Needle with MASTERGUARD Protector4R24414R24412016-09-02
00811137012435Apheresis Needle with MASTERGUARD™ Protector4R24404R24402016-09-02

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
04052682004193Fenwal Y-Type Blood Comp. Recipient Set with Std. Blood Filter and 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