FDA.reportPublic FDA data

NA

Primary DI
00811137012695
Brand
NA
Company
FENWAL, INC.
Model
4C2498H
Catalog number
4C2498H
Device description
Y-Type Connector Set with Luer Lock
Published
2016-09-12
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
KSBSet, Transfer (Blood/Plasma)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSBSet, Transfer (Blood/Plasma)Hematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811137012692PackageGS148In Commercial Distribution
00811137012695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081113701269210811137012692
00811137012695008111370126958111370126950811137012695

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfer setA collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). 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
Premarket exempt
true
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
00811137010400NA4C21614C21612016-09-12
00811137010431NA4C45024C45022016-09-12
00811137010455NA4C21604C21602016-09-12
00811137010691NA4C22234C22232016-09-12
00811137010714NA4C24684C24682016-09-12
00811137012411Apheresis Needle with MASTERGUARD Protector4R24414R24412016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
35020583260314SCD Welding WaferTERUMO BCT, INC.KSB2025-05-14
55020583260318SCD Welding WaferTERUMO BCT, INC.KSB2025-05-14
04987488104139K-Shield Advantage Blood Drawing KitSB-KAWASUMI LABORATORIES, INC.KSB2024-12-24
06976052440061BMSWuhan BMS Medicaltech Co., LtdKSB2023-01-27
16976052440068BMSWuhan BMS Medicaltech Co., LtdKSB2023-01-27
06976052440092BMSWuhan BMS Medicaltech Co., LtdKSB2023-01-27
00866305000264Genesis RapidWeld II STW Sterile Tube WelderGENESIS BPS LLCKSB2022-07-26
10866305000278TCD B40 WafersGENESIS BPS LLCKSB2022-07-19
10866305000230RapidWeld Blade Module KitGENESIS BPS LLCKSB2020-01-10
10866305000247RapidWeld Blade Module KitGENESIS BPS LLCKSB2020-01-10
10866305000254RapidWeld Blade Module KitGENESIS BPS LLCKSB2020-01-10
10866305000223TCD B40 WafersGENESIS BPS LLCKSB2019-10-29
00646311630033BLOOD DRAWING KIT WITH ANTINEEDLE STICK PROTECTOR AND NEEDLELESS ACCESS CONNECTOSB-KAWASUMI LABORATORIES, INC.KSB2019-02-26
00646311630040K-Shield Advantage Blood Drawing KitSB-KAWASUMI LABORATORIES, INC.KSB2019-02-13
00817827026171AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026188AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026195AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026201AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026218AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026676AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026683AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026690AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026706AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026713AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00887868260285Rejuvesol™Citra Labs, LLCKSB2018-07-13
14052682004169Fenwal Plasma Transfer Sets with Two SpikesFresenius Kabi AGKSB2018-05-29
24052682004166Fenwal Plasma Transfer Sets with Two SpikesFresenius Kabi AGKSB2018-05-29
00817827026010Advect™CHARTER MEDICAL, LTD.KSB2018-04-10
00817827026027Advect™CHARTER MEDICAL, LTD.KSB2018-04-10
00817827026034Advect™CHARTER MEDICAL, LTD.KSB2018-04-10