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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
Packages an Ebb Insomnia Therapy Starter kit with a replenish kit, 2 replacement cartridges and a travel bag. FDA UDI
Model / Reference
VA Kit FDA UDI
Description
Packages an Ebb Insomnia Therapy Starter kit with a replenish kit, 2 replacement cartridges and a travel bag. FDA UDI

Identifiers

Primary DI / UDI-DI
00864302000317 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

No

FDA UDI

Serial Number

Yes

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

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Manufacturer

Manufacturer
Cereve Inc

Sources (1)

  • FDA UDI b86f3f4b-b027-4f85-bd15-2a84e57a1130 33 fields · synced May 31, 2026