AccessGUDID - DEVICE: ThermaZone (00854682001615)

GUDID

Device Identifier (DI) Information

Brand Name: ThermaZone
Version or Model: 003-08
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 003-08
Company Name: INNOVATIVE MEDICAL EQUIPMENT, LLC

Primary DI Number: 00854682001615
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 833969186 *Terms of Use

Device Description: ThermaZone Thermal Therapy Device with medical grade power supply.

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):	Yes
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?
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.	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: between 60 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1f259e5d-0299-4c9d-98c4-b14d7e509bf9
Public Version Date: December 18, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2016