AccessGUDID - DEVICE: Brace Direct (00689481624044)

GUDID

Device Identifier (DI) Information

Brand Name: Brace Direct
Version or Model: CTY243
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BRACE ALIGN LLC

Primary DI Number: 00689481624044
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 108094498 *Terms of Use

Device Description: Experience the next level of pain relief with the Brace Direct BlueIce Cold Cryotherapy Machine. Perfect for arthritis, post-surgical recovery, and injury treatment, this machine combines portability and efficiency for targeted cold therapy.

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?
62442	Circulating-fluid localized thermal therapy system	An assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs (e.g., anatomically specific wraps), and a mains electricity (AC-powered) fluid pump and heating/cooling unit with controls/display; the device is not intended 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 001a49a9-9bd5-4257-8ff2-5189fec49ec9
Public Version Date: March 27, 2025
Public Version Number: 1
DI Record Publish Date: March 19, 2025