ALYX Plasma Kit 4R5730

GUDID 00811137012916

For Collection of Plasma Product by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.

FENWAL, INC.

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Primary Device ID00811137012916
NIH Device Record Key6d84b13a-cbed-4e59-b69a-e1477129756c
Commercial Distribution StatusIn Commercial Distribution
Brand NameALYX Plasma Kit
Version Model Number4R5730
Catalog Number4R5730
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS100811137012916 [Primary]
GS110811137012913 [Package]
Package: Carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKTSeparator, Automated, Blood Cell, Diagnostic

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 Date2016-09-08

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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