AccessGUDID - DEVICE: Ebb Insomnia Therapy (00864302000300)

GUDID

Device Identifier (DI) Information

Brand Name: Ebb Insomnia Therapy
Version or Model: EOS-30000-007
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CEREVE INC

Primary DI Number: 00864302000300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 877328174 *Terms of Use

Device Description: Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps.

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":	Yes
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?
62442	Circulating-fluid localized thermal therapy system	An assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs (e.g., anatomically specific wraps), and a mains electricity (AC-powered) fluid pump and heating/cooling unit with controls/display; the device is not intended for wrap inflation. It is intended for use in both professional and home settings.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLU	Thermal System For Insomnia

FDA Premarket Submission

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

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
Handling Environment Humidity: between 15 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 57 and 75 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: da03dc24-af5a-4aa8-827c-bfc9adc54aee
Public Version Date: December 18, 2023
Public Version Number: 3
DI Record Publish Date: October 30, 2017