AccessGUDID - DEVICE: SleepScout (B14360201292)

GUDID

Device Identifier (DI) Information

Brand Name: SleepScout
Version or Model: International Sensor Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 602-0129
Company Name: Cleveland Medical Devices Inc.

Primary DI Number: B14360201292
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 557510625 *Terms of Use

Device Description: Optional accessory kit for use with SleepScout - International customers

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:	Yes
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?
11467	Electroencephalograph	An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWQ	Full-Montage Standard Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042039	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: be550865-5f9c-42b2-9ca5-511d35f5a155
Public Version Date: August 09, 2023
Public Version Number: 5
DI Record Publish Date: September 23, 2016