GAME READY* MED4 Elite* System 650500-EN01

GUDID 00812120004499

GAME READY* MED4 Elite* System

Avanos Medical, Inc.

Circulating-fluid localized thermal/compression therapy system control unit

• Primary Device ID: 00812120004499
• NIH Device Record Key: 8defce11-b348-43f5-8983-af9c11917ca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GAME READY* MED4 Elite* System
• Version Model Number: 650500-EN01
• Catalog Number: 650500-EN01
• Company DUNS: 079375431
• Company Name: Avanos Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812120004499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171685

FDA Product Code

• ILO: Pack, hot or cold, water circulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-07
• Device Publish Date: 2024-10-30

Devices Manufactured by Avanos Medical, Inc.

• 10350770006076 - MIC PEG TUBE: 2025-03-04 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 14 Fr - PULL
• 10350770006083 - MIC PEG TUBE: 2025-03-04 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 24 Fr - PUSH OTW
• 10350770006090 - MIC PEG TUBE: 2025-03-04 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 24 Fr - PULL
• 10350770006120 - MIC PEG TUBE: 2025-03-04 MIC* Safety Percutaneous Endoscopic Gastrostomy PEG Kit - 24 Fr - PULL
• 10350770006137 - MIC PEG TUBE: 2025-03-04 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 14 Fr - PUSH OTW
• 10350770006144 - MIC PEG TUBE: 2025-03-04 MIC* Safety Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr - PUSH OTW
• 10350770006168 - MIC PEG TUBE: 2025-03-04 MIC* Safety Percutaneous Endoscopic Gastrostomy PEG Kit - 14 Fr - PUSH OTW
• 10350770006175 - MIC PEG TUBE: 2025-03-04 MIC* Safety Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr - PULL