Fenwal PLASMACELL-C Disposable Set 4R2252

GUDID 04086000101455

For Collection of Plasma by Membrane Filtration. For Use with the AUTOPHERESIS-C Instrument. Sterile Fluid Path.

Fresenius Kabi AG

Apheresis system tubing set
Primary Device ID04086000101455
NIH Device Record Keyb94314a3-82e8-4ac0-8959-234655056129
Commercial Distribution StatusIn Commercial Distribution
Brand NameFenwal PLASMACELL-C Disposable Set
Version Model Number4R2252
Catalog Number4R2252
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
GS104086000101455 [Primary]
GS114086000101452 [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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