COM.TEC

Basic Information

• Brand Name: COM.TEC
• Primary DI: 04086000860154
• Version / Model: 9008031
• Catalog Number: 9008031
• Company Name: Fresenius Kabi AG
• Labeler DUNS: 315654579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2018-09-03
• Public Version Status: Update
• Public Device Record Key: 93626510-b09e-4cd8-a8cc-58df845ce1dd

Device Description

The COM.TEC Blood Cell Separator is a blood cell separator which utilizes centrifugal force as the basis for operation. The fields of application are as follows: - Plasma exchange - Plasma treatment

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
16405	Apheresis system	An assembly of electrically-powered devices designed for the extracorporeal separation and removal of a constituent of whole blood (e.g., plasma, platelets, leukocytes) and pathogens, and the return of the remaining constituents to the patient. It typically includes pumps to circulate the blood and uses methods such as membrane filtration, centrifugation, adsorption, or a combination of these to separate the constituent from the blood. The system may be used therapeutically (e.g., to remove immune complexes or low density lipoproteins) or for the harvesting of blood constituents (e.g., for HLA-matched platelets or fresh frozen plasma).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04086000860154	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K060734	000