Identity
- Trade Name
- AqueCool FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
- Device Name
- The AqueCool Upper Face and Eyes Mask (UFAE) is a wearable, water circulating face mask. It covers from below the eyes to the top of the forehead and can provide compression. Embedded wire splint and flexible ear patches allow form-fitting to each user’s face. Eye Flaps can be secured in an upright position for visibility or can be brought down to assist in total facial recovery. 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 Upper Face and Eyes Mask (UFAE) is a wearable, water circulating face mask. It covers from below the eyes to the top of the forehead and can provide compression. Embedded wire splint and flexible ear patches allow form-fitting to each user’s face. Eye Flaps can be secured in an upright position for visibility or can be brought down to assist in total facial recovery. 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
- 00860008048332 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 2dc53e2d-a082-4715-99d6-9bd1a177f024 34 fields · synced May 30, 2026