Ebb Insomnia Therapy

GUDID 00864302000300

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.

CEREVE INC

Circulating-fluid thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system Circulating-fluid localized thermal therapy system
Primary Device ID00864302000300
NIH Device Record Keyda03dc24-af5a-4aa8-827c-bfc9adc54aee
Commercial Distribution StatusIn Commercial Distribution
Brand NameEbb Insomnia Therapy
Version Model NumberEOS-30000-007
Company DUNS877328174
Company NameCEREVE INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com
Phone800-381-1145
Emailcustomersuccess@ebbsleep.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 57 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100864302000300 [Primary]

FDA Product Code

PLUThermal System For Insomnia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-10-30

On-Brand Devices [Ebb Insomnia Therapy]

00864302000355Ebb Insomnia Therapy headgear assembly without the tube sleeve for clinical demonstrations to al
00864302000348Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and t
00864302000331Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and t
00864302000324Replenish kit including replacement fluid cartridge and headgear with tubing for the Ebb Insomni
00864302000300Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and t
00864302000317Packages an Ebb Insomnia Therapy Starter kit with a replenish kit, 2 replacement cartridges and

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