DOWN POLE CLAMP FOR AE
NA - A/0059-01
Device Description
A cart used to transport medical and surgical instruments, and sometimes sterile supplies, from a central supply station or sterilization department to appropriate areas of the hospital [e.g., the operating room (OR)]. In sterilizing departments the trolley may be used in the sterilizing process, and for sterilized instruments the cart may be designed to accommodate sterile wraps/packaging and/or cases. This trolley (cart) can be closed or open (open trolleys are usually covered with fabric during transport).
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 IdentifiersDevice Id: 00841983104114
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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