Game Ready Hip/Groin Wrap - Left - Demo 590604-03-DM

GUDID 00812120001658

Wrap Hip-Groin Left Demo

Avanos Medical, Inc.

Circulating-fluid thermal/compression therapy system wrap

• Primary Device ID: 00812120001658
• NIH Device Record Key: fb87097a-605b-49f4-bcdf-a19b61d1b9f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Game Ready Hip/Groin Wrap - Left - Demo
• Version Model Number: 590604-03-DM
• Catalog Number: 590604-03-DM
• 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	00812120001658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192114

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

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• 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