GAME READY* Med4 Elite* Accessory Kit 303945-EX08

GUDID 00812120004383

GAME READY* Med4 Elite* Accessory Kit - AR, ES

Avanos Medical, Inc.

Circulating-fluid localized thermal/compression therapy system control unit

• Primary Device ID: 00812120004383
• NIH Device Record Key: b8281cd6-0308-4b36-8c4e-7ebcfb37e21c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GAME READY* Med4 Elite* Accessory Kit
• Version Model Number: 303945-EX08
• Catalog Number: 303945-EX08
• 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: true
• Serial Number: false
• 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	00812120004383 [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

On-Brand Devices [GAME READY* Med4 Elite* Accessory Kit]

• 00812120004451: GAME READY* Med4 Elite* Accessory Kit - BR, PT
• 00812120004444: GAME READY* Med4 Elite* Accessory Kit - Japan, JP
• 00812120004383: GAME READY* Med4 Elite* Accessory Kit - AR, ES
• 00812120004352: GAME READY* Med4 Elite* Accessory Kit - NA, ES
• 00812120004345: GAME READY* Med4 Elite* Accessory Kit - CN, GB
• 00812120004338: GAME READY* Med4 Elite* Accessory Kit - KR, GB
• 00812120004321: GAME READY* Med4 Elite* Accessory Kit - IL, GB
• 00812120004307: GAME READY* Med4 Elite* Accessory Kit - AU, GB
• 00812120004284: GAME READY* Med4 Elite* Accessory Kit - CH, GB
• 00812120004260: GAME READY* Med4 Elite* Accessory Kit - UK, GB