FDA.reportPublic FDA data

Ebb Insomnia Therapy

Primary DI
00864302000324
Brand
Ebb Insomnia Therapy
Company
CEREVE INC
Model
10200
Device description
Replenish kit including replacement fluid cartridge and headgear with tubing for the Ebb Insomnia Therapy system.
Published
2018-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLUThermal System For Insomnia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLUThermal System For InsomniaNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864302000324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864302000324008643020003248643020003240864302000324

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid thermal therapy systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-381-1145customersuccess@ebbsleep.com

Regulatory Flags#

DUNS number
877328174
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864302000317Ebb Insomnia TherapyVA Kit2019-05-31
00864302000300Ebb Insomnia TherapyEOS-30000-0072017-10-30
00864302000331Ebb Insomnia TherapyEOS-30000-0312018-01-17
00864302000348Ebb Insomnia TherapyEOS-30000-0132018-01-17
00864302000355Ebb Insomnia TherapyEOS-30000-054104012018-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864302000317Ebb Insomnia TherapyCEREVE INCPLU2019-05-31
00864302000355Ebb Insomnia TherapyCEREVE INCPLU2018-05-07
00864302000331Ebb Insomnia TherapyCEREVE INCPLU2018-01-17
00864302000348Ebb Insomnia TherapyCEREVE INCPLU2018-01-17
00864302000300Ebb Insomnia TherapyCEREVE INCPLU2017-10-30