FDA.reportPublic FDA data

Ebb Insomnia Therapy

Primary DI
00864302000355
Brand
Ebb Insomnia Therapy
Company
CEREVE INC
Model
EOS-30000-054
Catalog number
10401
Device description
Ebb Insomnia Therapy headgear assembly without the tube sleeve for clinical demonstrations to allow the tubing to be wiped down for cleaning.
Published
2018-05-07
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
00864302000355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864302000355008643020003558643020003550864302000355

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
00864302000324Ebb Insomnia Therapy102002018-01-22
00864302000331Ebb Insomnia TherapyEOS-30000-0312018-01-17
00864302000348Ebb Insomnia TherapyEOS-30000-0132018-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864302000317Ebb Insomnia TherapyCEREVE INCPLU2019-05-31
00864302000324Ebb Insomnia TherapyCEREVE INCPLU2018-01-22
00864302000331Ebb Insomnia TherapyCEREVE INCPLU2018-01-17
00864302000348Ebb Insomnia TherapyCEREVE INCPLU2018-01-17
00864302000300Ebb Insomnia TherapyCEREVE INCPLU2017-10-30