| Primary Device ID | 00815871021081 |
| NIH Device Record Key | 55ec14df-044c-4feb-a2db-0f42daa01b6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Waveline Pro+ |
| Version Model Number | 60146 |
| Company DUNS | 178440426 |
| Company Name | Avante |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815871021081 [Primary] |
| DSI | Detector And Alarm, Arrhythmia |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2016-09-23 |
| 00815871021418 | 60146TESP |
| 00815871021173 | 60146TNSI |
| 00815871021166 | 60146TCO2FE |
| 00815871021159 | 60146TCO2F |
| 00815871021142 | 60146TCO2 |
| 00815871021135 | 60146TCB |
| 00815871021128 | 60146TC |
| 00815871021111 | 60146NESTA |
| 00815871021104 | 60146NEST |
| 00815871021098 | 60146CO2 |
| 00815871021081 | 60146 |