AMICUS Apheresis Kit – Double Needle with Platelet Additive Solution Connector X6R2302

GUDID 14086000100967

AMICUS Apheresis Kit – Double Needle with Platelet Additive Solution Connector

Fresenius Kabi AG

Apheresis system tubing set
Primary Device ID14086000100967
NIH Device Record Key99c700a6-3ece-4ad9-aa6d-be630581dda9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMICUS Apheresis Kit – Double Needle with Platelet Additive Solution Connector
Version Model NumberX6R2302
Catalog NumberX6R2302
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 *Storage and Handling as defined on label

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000100960 [Primary]
GS114086000100967 [Package]
Contains: 04086000100960
Package: Carton [6 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 Date2020-07-01
Device Publish Date2020-06-23

Devices Manufactured by Fresenius Kabi AG

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10810020441649 - Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual2024-02-01 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F
14086000101032 - ALYX 2RBC-LR Kit with Saline Spike2023-12-21 For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use with the ALYX System. Sterile fluid path.
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00810020441208 - AMICUS Separator Legacy Software2023-05-31 Software version for AMICUS Separator Legacy Device
10810020440277 - AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike2023-05-30 For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Sol
10810020440765 - AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike2023-05-30 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F
10810020441113 - PLASMACELL Xi Disposable Set with SPIKESMART2023-03-06 For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile Fluid Path.

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