Identity
- Trade Name
- CB240_Aurora FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
- Model / Reference
- CB240C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08050593470027 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Circulating-fluid localized thermal therapy system pack, single-use
CB240_Aurora by Neuron Guard Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Circulating-fluid localized thermal therapy system pack, single-use.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- BREG — Breg, Inc. · Class II
- Soft-Temp — Adroit Medical Systems, Inc. · Class II
- Cold Rush — OSSUR AMERICAS · Class II
- BREG — Breg, Inc. · Class II
- Top Shelf Orthopedics — Top Shelf Manufacturing, LLC · Class II
- Top Shelf Orthopedics — Top Shelf Manufacturing, LLC · Class II
- Cold Therapy Temp-Pads® — Gentherm Medical, LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neuron Guard Srl
Sources (2)
- FDA UDI a3b4ed6a-c6d9-4d63-8c64-d486226deb02 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026