DEVICE: ATLAS Power Isolator 220VAC (00850011306994)
Device Identifier (DI) Information
ATLAS Power Isolator 220VAC
220VAC
In Commercial Distribution
31-0607-0009
NEURALYNX, INC.
220VAC
In Commercial Distribution
31-0607-0009
NEURALYNX, INC.
An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patient leakage current to an acceptable level.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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16936 | Uninterruptible power supply system |
An assembly of static devices, commonly known as an uninterruptible power supply (UPS), that is connected to the line power system of a hospital or institution to provide an independent continuous supply of electrical power, without delay, whilst the backup generators start. It will supply selected areas of high importance [i.e., operating theatres, the intensive care unit (ICU), the information technology (IT) department] for a limited period of time during the failure of the mains electricity (AC-power) supply. It will consist of a large set of dedicated batteries, battery chargers, and electronics that monitor and switch over to this system when a failure in the line-power has occurred.
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FDA Product Code
[?]Product Code | Product Code Name |
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OMC | Reduced- Montage Standard Electroencephalograph |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K110967 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
31e54550-79b9-47a1-97a5-d3de9f92f167
December 19, 2024
1
December 11, 2024
December 19, 2024
1
December 11, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined