AccessGUDID - DEVICE: AqueCool (00860008048318)

GUDID

Device Identifier (DI) Information

Brand Name: AqueCool
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Advanced Ambulatory, Inc.

Primary DI Number: 00860008048318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 165086757 *Terms of Use

Device Description: The AqueCool Full Face and Neck Mask (FFAN) is a two part, wearable, water circulating face mask. It covers from below the jawline to the top of the forehead and can provide compression. Embedded wire splints and flexible chin and 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILO	Pack, Hot Or Cold, Water Circulating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 33774d23-8c2d-43a3-84d0-4aee8e1d83e2
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 2024