AqueCool

Basic Information

• Brand Name: AqueCool
• Primary DI: 00860008048325
• 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: 4559987a-10a7-4130-b5ad-4f84516e3e75

Device 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

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: No
• Has Lot/Batch Number: Yes
• 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
40485	Circulating-fluid localized thermal therapy system pack, single-use	A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00860008048356	GS1		10	In Commercial Distribution
Primary	00860008048325	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 45 Degrees Celsius