AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector L6R2337

GUDID 14086000100059

For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For use with the AMICUS Separator.

Fresenius Kabi AG

Apheresis system tubing set
Primary Device ID14086000100059
NIH Device Record Key9a716b6f-2379-4b36-931d-bc58982bc544
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector
Version Model NumberL6R2337
Catalog NumberL6R2337
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 Datetrue
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.
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.
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.
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
GS104086000100052 [Primary]
GS114086000100059 [Package]
Contains: 04086000100052
Package: Carton [3 Units]
In Commercial Distribution

FDA Product Code

GKTSeparator, Automated, Blood Cell, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-07
Device Publish Date2024-10-30

On-Brand Devices [AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector]

14086000100950AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector
14086000100059For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in
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