AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly 4R2354G

GUDID 00810020440140

For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.

Fresenius Kabi AG

Apheresis system tubing set
Primary Device ID00810020440140
NIH Device Record Key9d647c71-bddd-4427-8d3b-7249962cbbe7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly
Version Model Number4R2354G
Catalog Number4R2354G
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 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
GS100810020440140 [Primary]
GS110810020440147 [Package]
Package: Carton [3 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-28
Device Publish Date2020-10-20

Devices Manufactured by Fresenius Kabi AG

14086000100059 - AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector2024-11-07 For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Sol
04086000860888 - COMPOGUARD Advance Basic2024-11-07 Device, Blood Mixing and Weighing
04086000860895 - COMPOGUARD Advance Data2024-11-06 Device, Blood Mixing and Weighing
04086000860901 - COMPOGUARD Advance COMPLETE2024-11-06 Device, Blood Mixing and Weighing
00810020440591 - AMICUS Separator Legacy Software2024-04-04 Software version for AMICUS Separator Legacy Device
00810020440607 - AMICUS Separator Life Extension Software2024-04-04 Software version for AMICUS Separator Life Extension Device
04250273750164 - Volumat™ Line2024-03-29 IV administration set for infusion pumps
04250273750218 - Volumat™ Line2024-03-29 IV administration set for infusion pumps

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.