SedLine Patient Cable

SedLine Patient Cable - 2480

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GWQ

Device Name: Full-Montage Standard Electroencephalograph

Device Class: 2

Physical State: May include standard electroencephalograph recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data). Does NOT include electrodes, more complex software used to analyze electroencephalograph data or automatically detect events, electroencephalograph used for polysomnography or sleep studies, or electroencephalograph with less than 16 electrodes.

Definition: Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses electrodes (16 or more) placed on the scalp or within the brain, via user-specified locations, to record and display electrical activity of the brain

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Brain

Regulation Number: 882.1400

Third Party Flag: Y

Medical Specialty: NE

Device Id: 00843997005814

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