AqueCool

Basic Information

• Brand Name: AqueCool
• Primary DI: 00860008048301
• Version / Model: 1.0
• Company Name: Advanced Ambulatory, Inc.
• Labeler DUNS: 165086757
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-19
• Public Version: 1
• Public Version Date: 2024-07-29
• Public Version Status: New
• Public Device Record Key: 02f89b58-63ad-4102-966a-23edcc1c84ea

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	890.5720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42463	Circulating-fluid localized thermal therapy system control unit	An electrically-powered device intended to be used as part of a localized circulating-fluid thermal therapy system to pump heated and/or cooled fluid (e.g., water) through an externally applied pack (not included) for localized hot and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It includes a fluid pump and either a heater, or a means for cold therapy (e.g., refrigeration unit, permitting addition of independently cooled ice water) or both; it does not include an air pump for wrap inflation. It is intended for use in both professional and home settings.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008048301	GS1