C.A.T.S 9005081

GUDID 04086000860031

The C.A.T.S (Continuous Autotransfusion System) device by Fresenius is an autotransfusion device indicated for the processing of autologous shed blood

Fresenius Kabi AG

Blood-processing autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system
Primary Device ID04086000860031
NIH Device Record Key90b76747-ab4f-4db4-b584-168ff9139b19
Commercial Distribution StatusIn Commercial Distribution
Brand NameC.A.T.S
Version Model Number9005081
Catalog Number9005081
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4961726868436
Emaildieter.fries@fresenius-kabi.co
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com
Phone+4961726868436
Emaildieter.fries@fresenius-kabi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000860031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACApparatus, Autotransfusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-03
Device Publish Date2015-09-01

Devices Manufactured by Fresenius Kabi AG

10810020441632 - Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual2024-02-01 For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Sol
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.
00810020441192 - AMICUS Separator Life Extension Software2023-06-01 Software version for AMICUS Separator Life Extension Device
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.

Trademark Results [C.A.T.S]

Mark Image

Registration | Serial
Company
Trademark
Application Date
C.A.T.S
C.A.T.S
75129519 2194092 Live/Registered
FRESENIUS SE & CO. KGAA
1996-07-03

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