| Primary Device ID | 10193493000323 |
| NIH Device Record Key | b0cdea4d-d87a-47f4-b662-77a20d2b48db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COOLIEF* |
| Version Model Number | CRX-BAY-CRP |
| Catalog Number | CRX-BAY-CRP |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00193493000326 [Primary] |
| GS1 | 10193493000323 [Package] Contains: 00193493000326 Package: CS [20 Units] In Commercial Distribution |
| 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 | 2022-03-21 |
| Device Publish Date | 2022-03-12 |
| 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 |