| Primary Device ID | 00193493000319 | 
| NIH Device Record Key | 0384aab8-0308-4697-8b59-1bcaf66e4b93 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | COOLIEF* | 
| Version Model Number | CRX-BAY-MCRF | 
| Catalog Number | CRX-BAY-MCRF | 
| 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 | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | |
| Phone | +1(844)428-2667 | 
| PIQ@AVANOS.COM | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00193493000319 [Primary] | 
| GXI | Probe, radiofrequency lesion | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-03-25 | 
| Device Publish Date | 2022-03-17 | 
| 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 |