4C2161

GUDID 10811137010407

Y-Type Blood component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Fluid Path

FENWAL, INC.

Blood transfusion set Blood transfusion set
Primary Device ID10811137010407
NIH Device Record Key9f0912e9-51b2-4f69-98fb-8403b1645eda
Commercial Distribution Discontinuation2018-03-11
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number4C2161
Catalog Number4C2161
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
GS100811137010400 [Primary]
GS110811137010407 [Package]
Contains: 00811137010400
Package: Box [48 Units]
Discontinued: 2018-03-11
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BRZSet, Blood Transfusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
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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