Identity
- Trade Name
- Ebb Insomnia Therapy FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system FDA UDI
- Device Name
- Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps. This listing is for the replacement forehead pad with tubing. FDA UDI
- Model / Reference
- EOS-30000-013 FDA UDI
- Description
- Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps. This listing is for the replacement forehead pad with tubing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864302000348 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
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cereve Inc
Sources (1)
- FDA UDI 268f7e20-eb61-4d0c-9637-4c48f28102ae 34 fields · synced May 31, 2026