AccessGUDID - DEVICE: ATLAS Rackmounted Power Isolator (00850011306239)

GUDID

Device Identifier (DI) Information

Brand Name: ATLAS Rackmounted Power Isolator
Version or Model: ATLAS Rackmounted Power Isolator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-0607-0015
Company Name: NEURALYNX, INC.

Primary DI Number: 00850011306239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 933200842 *Terms of Use

Device Description: 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 in a rack mounted form factor.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMC	Reduced- Montage Standard Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110967	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b8bc6579-680d-455f-b545-10d228f4c3cc
Public Version Date: December 19, 2024
Public Version Number: 1
DI Record Publish Date: December 11, 2024