FDA.reportPublic FDA data

NA

Primary DI
00811137010431
Brand
NA
Company
FENWAL, INC.
Model
4C4502
Catalog number
4C4502
Device description
Sepacell PLD-10ALeukocyte Reduction Y-Administration Set. Sterile Fluid Path
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
CAKMicrofilter, Blood Transfusion

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9400400

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9400400

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811137010438PackageGS118In Commercial Distribution
00811137010431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081113701043810811137010438
00811137010431008111370104318111370104310811137010431

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
00811137010400NA4C21614C21612016-09-12
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
10810197810460GVSGvs Tm, Inc.CAK2026-02-19
20810197810467GVSGvs Tm, Inc.CAK2026-02-19
10810197810170GVSGvs Tm, Inc.CAK2026-01-19
20810197810177GVSGvs Tm, Inc.CAK2026-01-19
04052682004308LeukoconnectFresenius Kabi AGCAK2022-06-02
14052682004305LeukoconnectFresenius Kabi AGCAK2022-06-02
10887691000178HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
10887691000543HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
30887691000172HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
30887691000547HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
10887691000666HaemoneticsHAEMONETICS CORPORATIONCAK2021-03-19
30887691000660HaemoneticsHAEMONETICS CORPORATIONCAK2021-03-19
20887691308745Leukocyte SC RCHAEMONETICS CORPORATIONCAK2017-06-16
30887691308742Leukocyte SC RCHAEMONETICS CORPORATIONCAK2017-06-16
10887691000673HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
10887691305792HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
30887691000677HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
30887691305796HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
10887691000550PXL 8HAEMONETICS CORPORATIONCAK2017-02-02
10887691000581RCXL1HAEMONETICS CORPORATIONCAK2017-02-02
10887691000680HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-02
30887691000554PXL 8HAEMONETICS CORPORATIONCAK2017-02-02
30887691000585RCXL1HAEMONETICS CORPORATIONCAK2017-02-02
30887691000684HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-02
10887691000758HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
10887691001243LipiGuard SBHAEMONETICS CORPORATIONCAK2017-01-19
10887691304214Haemonetics Leukotrap SC RCHAEMONETICS CORPORATIONCAK2017-01-19
10887691305303HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
30887691000752HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
30887691001247LipiGuard SBHAEMONETICS CORPORATIONCAK2017-01-19