Ebb Insomnia Therapy

GUDID 00864302000348

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. This listing is for the replacement forehead pad with tubing.

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 ID00864302000348
NIH Device Record Key268f7e20-eb61-4d0c-9637-4c48f28102ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameEbb Insomnia Therapy
Version Model NumberEOS-30000-013
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100864302000348 [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 Date2018-01-17

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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