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Device Description

A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 35021791000822

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05021791000821

Package Quantity: 50

Package Discontinue Date: 1/15/2021 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 05021791000821

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

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