Ebb Insomnia Therapy

GUDID 00864302000317

Packages an Ebb Insomnia Therapy Starter kit with a replenish kit, 2 replacement cartridges and a travel bag.

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 ID00864302000317
NIH Device Record Keyb86f3f4b-b027-4f85-bd15-2a84e57a1130
Commercial Distribution StatusIn Commercial Distribution
Brand NameEbb Insomnia Therapy
Version Model NumberVA Kit
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100864302000317 [Primary]

FDA Product Code

PLUThermal System For Insomnia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-10
Device Publish Date2019-05-31

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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