AccessGUDID - DEVICE: C.A.T.S (04086000860031)

GUDID

Device Identifier (DI) Information

Brand Name: C.A.T.S
Version or Model: 9005081
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9005081
Company Name: Fresenius Kabi AG

Primary DI Number: 04086000860031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: The C.A.T.S (Continuous Autotransfusion System) device by Fresenius is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34863	Red blood cell-recovery autotransfusion system	An assembly of devices designed to collect and process blood lost by a patient to obtain red blood cells for subsequent reinfusion into the same patient (i.e., autotransfusion). It typically includes a disposable suction system to collect blood from the surgical field, a reservoir to store the blood, a spinning processing chamber (e.g., a centrifuge) to separate waste (e.g., clotting factors, debris) and wash the red blood cells with saline, particulate microfilters, and a reinfusion bag that stores the red blood cells in saline. The system is used mainly during surgical procedures to minimize allogeneic blood use, but may be used postoperatively and in emergency or intensive care units.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CAC	Apparatus, Autotransfusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960006	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90b76747-ab4f-4db4-b584-168ff9139b19
Public Version Date: January 08, 2021
Public Version Number: 5
DI Record Publish Date: September 01, 2015