Game Ready Med4 Accessory Kit 303945-EN01

GUDID 00812120003591

303945-EN01 Accessory Kit, Med4 Elite, NA, GB

Avanos Medical, Inc.

Circulating-fluid thermal/compression therapy system wrap

• Primary Device ID: 00812120003591
• NIH Device Record Key: c718e2a9-0b31-4bf7-a593-a12edb9223a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Game Ready Med4 Accessory Kit
• Version Model Number: 303945-EN01
• Catalog Number: 303945-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: 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
• 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	00812120003591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171685

FDA Product Code

• IRP: Massager, powered inflatable tube

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: 2023-04-13
• Device Publish Date: 2023-04-05

On-Brand Devices [Game Ready Med4 Accessory Kit]

• 00812120003805: 303945-PB07 Accessory Kit, Med4 Elite, BR, PT
• 00812120003799: 303945-JA12 Accessory Kit, Med4 Elite, Japan, JP
• 00812120003768: 303945-FR06 Accessory Kit, Med4 Elite, CH, FR
• 00812120003744: 303945-FR01 Accessory Kit, Med4 Elite, NA, FR
• 00812120003737: 303945-EX08 Accessory Kit, Med4 Elite, AR, ES
• 00812120003706: 303945-EX01 Accessory Kit, Med4 Elite, NA, ES
• 00812120003690: 303945-EN14 Accessory Kit, Med4 Elite, CN, GB
• 00812120003683: 303945-EN13 Accessory Kit, Med4 Elite, KR, GB
• 00812120003676: 303945-EN11 Accessory Kit, Med4 Elite, IL, GB
• 00812120003669: 303945-EN10 Accessory Kit, Med4 Elite, DK, GB
• 00812120003652: 303945-EN09 Accessory Kit, Med4 Elite, AU, GB
• 00812120003645: 303945-EN07 Accessory Kit, Med4 Elite, BR, GB
• 00812120003638: 303945-EN06 Accessory Kit, Med4 Elite, CH, GB
• 00812120003621: 303945-EN05 Accessory Kit, Med4 Elite, IN, GB
• 00812120003614: 303945-EN03 Accessory Kit, Med4 Elite, UK, GB
• 00812120003591: 303945-EN01 Accessory Kit, Med4 Elite, NA, GB
• 00812120003560: 303945-AR03 Accessory Kit, Med4 Elite, UK, SA