PLASMACELL Xi Disposable Set with SPIKESMART 6R2600

GUDID 04086000101097

For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile Fluid Path.

Fresenius Kabi AG

Apheresis system tubing set
Primary Device ID04086000101097
NIH Device Record Keyb2355055-0e62-47b4-9b44-d801b25d7ee2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLASMACELL Xi Disposable Set with SPIKESMART
Version Model Number6R2600
Catalog Number6R2600
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
GS104086000101097 [Primary]
GS114086000101094 [Package]
Package: Carton [24 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 Date2017-01-31

On-Brand Devices [PLASMACELL Xi Disposable Set with SPIKESMART]

04086000101097For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile
10810020441113For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile

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