← Back to catalogue

Ebb Insomnia Therapy

FDA UDI

Class II (US FDA UDI)

by Cereve Inc

Identity

Trade Name
Ebb Insomnia Therapy FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system FDA UDI
Device Name
Ebb Insomnia Therapy headgear assembly without the tube sleeve for clinical demonstrations to allow the tubing to be wiped down for cleaning. FDA UDI
Model / Reference
EOS-30000-054 FDA UDI
Description
Ebb Insomnia Therapy headgear assembly without the tube sleeve for clinical demonstrations to allow the tubing to be wiped down for cleaning. FDA UDI

Identifiers

Catalog Number
10401 FDA UDI
Primary DI / UDI-DI
00864302000355 FDA UDI
FDA Product Code
PLU FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Circulating-fluid localized thermal therapy system

Ebb Insomnia Therapy by Cereve Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal therapy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cereve Inc

Sources (1)

  • FDA UDI c6d34a49-960c-48a2-8888-672fe80a79c2 35 fields · synced May 30, 2026