AccessGUDID - DEVICE: ARTEK PRO-01 WRAP (00850033615050)

GUDID

Device Identifier (DI) Information

Brand Name: ARTEK PRO-01 WRAP
Version or Model: 0P9BATPUNVWRC01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0P9BATPUNVWRC01
Company Name: THERMOTEK, INC.

Primary DI Number: 00850033615050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 847899911 *Terms of Use

Device Description: WRAP, ARTEK PRO-01, UNV COMP01

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:	Yes
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?
60708	Circulating-fluid localized thermal/compression therapy system wrap	A non-sterile component of a circulating-fluid localized thermal/compression therapy system intended to facilitate, through thermal therapy (heating and/or cooling) and compression, the treatment of a variety of adverse conditions resulting from a musculoskeletal injury/orthopaedic surgery (e.g., pain, swelling, inflammation). It is intended to be fastened around a single or multiple anatomies and consists of: a heat exchanger, which enables heated and/or cooled fluid from the system control unit to be circulated; and an external sleeve, which enables intermittent compression via inflation. It is intended for use in both professional and home settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILO	Pack, Hot Or Cold, Water Circulating
JOW	Sleeve, Limb, Compressible

FDA Premarket Submission

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a588fc10-898d-44ac-b072-7b2e4156aaff
Public Version Date: December 18, 2023
Public Version Number: 2
DI Record Publish Date: March 01, 2023