4C4502

GUDID 10811137010438

Sepacell PLD-10ALeukocyte Reduction Y-Administration Set. Sterile Fluid Path

FENWAL, INC.

Blood transfusion set
Primary Device ID10811137010438
NIH Device Record Key726468b0-509c-4bfe-aa3b-899ad988cfa1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number4C4502
Catalog Number4C4502
Company DUNS794519020
Company NameFENWAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-933-6925
Emailxx@xx.xx
Phone1-800-933-6925
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100811137010431 [Primary]
GS110811137010438 [Package]
Contains: 00811137010431
Package: [18 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAKMicrofilter, Blood Transfusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

Devices Manufactured by FENWAL, INC.

20811137010626 - Transfer Pack2023-04-21 Quadruple Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path
20811137010497 - Transfer Pack2022-06-17 Transfer Pack Container 1000 mL with Coupler. Sterile Fluid Path
20811137010619 - Transfer Pack2022-06-17 Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path
20811137010541 - Transfer Pack2019-11-08 Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path
0FE04R2024 - Transfer Pack2019-11-08 Transfer Pack Container 600 mL with Male Luer Adapter. Sterile Fluid Path
20811137010633 - Transfer Pack2019-11-08 Transfer Pack Container 600 mL with Coupler. Sterile Fluid Path
20811137010657 - NA2019-11-08 Plasma Transfer Sets with Spike and Male Luer Adapter. Sterile Fluid Path
20811137010701 - NA2019-11-08 Plasma Transfer Sets with Two Spikes. Sterile Fluid Path

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