TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACE – Lite

TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACE – Lite
TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACE - 94010

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 Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OUG

Device Name: Medical Device Data System

Device Class: 1

Physical State: Software and Electronics

Definition: A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Software algorithms to perform necessary medical communication functions

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Hospital Information Systems

Regulation Number: 880.6310

Third Party Flag: N

Medical Specialty: HO

Device Id: 05020583940109

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A