AccessGUDID - DEVICE: AVACEN (00862800000396)

GUDID

Device Identifier (DI) Information

Brand Name: AVACEN
Version or Model: AVACEN HOME XL 5-YEAR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AVACEN MEDICAL, INC

Primary DI Number: 00862800000396
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832744754 *Terms of Use

Device Description: The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.

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):	Yes
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?
62194	Electric pad localized-body heating system	An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133981	000

Device Exempt from Premarket Submission: No 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 Atmospheric Pressure: between 500 and 1600 millibar
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 60 Degrees Celsius
Storage Environment Temperature: between 32 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea104b60-b95e-4974-bbac-6e66f012b00a
Public Version Date: March 20, 2023
Public Version Number: 1
DI Record Publish Date: March 10, 2023