AccessGUDID - DEVICE: Game Ready Med4 Elite Therapy Hose Assembly

GUDID

Device Identifier (DI) Information

Brand Name: Game Ready Med4 Elite Therapy Hose Assembly - Patient 1
Version or Model: 503647
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 503647
Company Name: Avanos Medical, Inc.

Primary DI Number: 00812120004031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: Therapy Hose Assembly #1 MED4 Elite

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?
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
IRP	Massager, powered inflatable tube

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171685	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 599f1005-3dae-4ecd-b3bb-a4acbeb91e2d
Public Version Date: December 18, 2023
Public Version Number: 2
DI Record Publish Date: April 05, 2023