SW APP A901 COMM MANAGER

SW APP A901 COMM MANAGER
N/A - A901

An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.

No Data Available

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: 00643169738058

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