AMICUS Exchange Kit - Therapeutics X6R2349

GUDID 04086000101950

For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path.

Fresenius Kabi AG

Therapeutic plasma/red blood cell exchange tubing set
Primary Device ID04086000101950
NIH Device Record Keyd414ac03-5718-4198-87f8-5d080b5c99f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMICUS Exchange Kit - Therapeutics
Version Model NumberX6R2349
Catalog NumberX6R2349
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
GS104086000101950 [Primary]
GS114086000101957 [Package]
Package: Shipping Carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-20

Devices Manufactured by Fresenius Kabi AG

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04086000860895 - COMPOGUARD Advance Data2024-11-06 Device, Blood Mixing and Weighing
04086000860901 - COMPOGUARD Advance COMPLETE2024-11-06 Device, Blood Mixing and Weighing
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