Fenwal PLASMACELL-C Disposable Set For Use With SP 4R2256

GUDID 04086000101356

For Collection of Virtually Cell Free Plasma by Membrane Filtration. For Use with the AURORA Instrument or the AUTOPHERESIS-C Instrument. Sterile Flui

Fresenius Kabi AG

Apheresis system tubing set
Primary Device ID04086000101356
NIH Device Record Key22c87499-4f88-45db-a3be-9edb8c3d3cb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameFenwal PLASMACELL-C Disposable Set For Use With SP
Version Model Number4R2256
Catalog Number4R2256
Company DUNS315654579
Company NameFresenius Kabi AG
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 Room Temperature. Protect from freezing. Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000101356 [Primary]
GS114086000101353 [Package]
Package: Carton [60 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 Date2016-09-02

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