COOLIEF* CRI-17-150-6

GUDID 10193493442109

COOLIEF* Cooled Radiofrequency Introducer

Avanos Medical, Inc.

Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator

• Primary Device ID: 10193493442109
• NIH Device Record Key: 3aa061c5-147c-42ee-b764-f6d4f4bdc6ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COOLIEF*
• Version Model Number: CRI-17-150-6
• Catalog Number: CRI-17-150-6
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193493442102 [Primary]
GS1	10193493442109 [Package]; Contains: 00193493442102; Package: CS [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053082

FDA Product Code

• GXI: Probe, radiofrequency lesion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-04
• Device Publish Date: 2021-01-27

On-Brand Devices [COOLIEF*]

• 00193493473038: COOLIEF* Cooled RF Advanced-R Generator, QTY 1
• 00193493473021: COOLIEF* Basic-R Generator, QTY 1
• 10193493442109: COOLIEF* Cooled Radiofrequency Introducer
• 10193493000323: COOLIEF* Cooled Radiofrequency Connector Cable
• 00193493000319: COOLIEF* Multi-Cooled Radiofrequency Module
• 10193493000279: COOLIEF* Cooled Radiofrequency Peristaltic Pump Connector Cable
• 10193493000262: COOLIEF* TRANSDISCAL* Cooled Radiofrequency Connector Cable
• 00193493000692: COOLIEF* Quad Pump Connector Cable