Identity
- Trade Name
- AqueCool FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
- Device Name
- The AqueCool Lower Face and Neck Mask (LFAN) is a wearable water circulating face mask. It covers from below the jawline up to the top of the cheek and can provide compression. Embedded wire splints and flexible chin and ear patches allow form-fitting to each user’s face. When used in conjunction with the AqueCool Device, the mask delivers cool water within the wearable bladder, wicking excess heat away from recovering tissue. Storage Temperature < 45C FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- The AqueCool Lower Face and Neck Mask (LFAN) is a wearable water circulating face mask. It covers from below the jawline up to the top of the cheek and can provide compression. Embedded wire splints and flexible chin and ear patches allow form-fitting to each user’s face. When used in conjunction with the AqueCool Device, the mask delivers cool water within the wearable bladder, wicking excess heat away from recovering tissue. Storage Temperature < 45C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008048325 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
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
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
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 4559987a-10a7-4130-b5ad-4f84516e3e75 34 fields · synced May 30, 2026