AccessGUDID - DEVICE: Echo Polysomnography Playback Unit (00817111020540)

GUDID

Device Identifier (DI) Information

Brand Name: Echo Polysomnography Playback Unit
Version or Model: ECHO320
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Neurotronics, LLC

Primary DI Number: 00817111020540
Issuing Agency: GS1
Commercial Distribution End Date: May 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 036405363 *Terms of Use

Device Description: No description.

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):	No
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?
36938	Electroencephalograph tester	A device used to perform quality control procedures on an electroencephalograph (EEG) machine and/or a sleep recording machine. It is intended to be used by a healthcare provider in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWR	Generator, Electroencephalograph Test Signal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: b10cffbc-b0c8-455a-b90c-e120488c5f1e
Public Version Date: May 10, 2024
Public Version Number: 2
DI Record Publish Date: June 07, 2023