AccessGUDID - DEVICE: CATSmart (04086000860048)

GUDID

Device Identifier (DI) Information

Brand Name: CATSmart
Version or Model: 9005901
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9005901
Company Name: Fresenius Kabi AG

Primary DI Number: 04086000860048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: The CATSmart (Continuous Autotransfusion System) by Fresenius is 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?
66789	Autotransfusion system blood collection/processing pump	An electrically-powered device intended to be used in conjunction with a collection of appropriate containers and tubing (not included) to produce pressure for the collection of blood from a patient and the subsequent processing (filter/wash) of the blood components (e.g., red or white blood cells, platelets) as part of an autotransfusion procedure. It typically incorporates a peristaltic and aspiration (suction) pump. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAC	Apparatus, Autotransfusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160735	000
K180831	000
K192368	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: 8d088e78-74c9-4591-a7f2-805a2295d824
Public Version Date: June 22, 2023
Public Version Number: 6
DI Record Publish Date: September 26, 2016