Identity
- Trade Name
- AqueCool FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system control unit FDA UDI
- Device Name
- The AqueCool Device, in conjunction with AqueCool masks, pumps cooled water across recovering tissue to wick away excess heat. The device is controllable between 50 and 65 Degrees Fahrenheit and utilizes a 6 foot tube set to allow the device to remain on the floor while in operation. Simple On/Off power button and temperature control knob on top of device allow user to easily adjust temperature or turn device off. The AqueCool system requires a standard 120VAC wall receptacle and 8-10oz of distilled water to operate. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- The AqueCool Device, in conjunction with AqueCool masks, pumps cooled water across recovering tissue to wick away excess heat. The device is controllable between 50 and 65 Degrees Fahrenheit and utilizes a 6 foot tube set to allow the device to remain on the floor while in operation. Simple On/Off power button and temperature control knob on top of device allow user to easily adjust temperature or turn device off. The AqueCool system requires a standard 120VAC wall receptacle and 8-10oz of distilled water to operate. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008048301 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system control unit 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Circulating-fluid localized thermal therapy system control unit
AqueCool by Advanced Ambulatory, 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
- Advanced Ambulatory, Inc.
Sources (1)
- FDA UDI 02f89b58-63ad-4102-966a-23edcc1c84ea 33 fields · synced May 30, 2026