- Physicians Office Resource

Neuro unit, 8 channel
NA - AE-918P

Device Description

An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

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: OMA

Device Name: Amplitude-Integrated 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 the amplitude-integrated electroencephalograph signal, software used to automatically detect events, electroencephalograph used for polysomnography or sleep studies, or standard electroencephalograph (full- or reduced- montage).

Definition: Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses a specific combination of filters, a semi-logarithmic scale and bipolar electrode placements (via user-specified and/or sponsor-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 Identifiers

Device Id: 00841983100017

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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