| Primary Device ID | 00815871021944 |
| NIH Device Record Key | 2772d605-daef-4f0d-a84a-d365f21eb79e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Waveline Touch |
| Version Model Number | 8857 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815871021944 [Primary] |
| MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) |
| 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 | 2016-09-24 |
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| 00815871020190 - Compact FM | 2020-03-02 |
| 00815871020206 - Compact FM | 2020-03-02 |
| 00815871020213 - Compact FM | 2020-03-02 |
| 00815871020220 - Compact FM | 2020-03-02 |
| 00815871020237 - Compact Plus | 2020-03-02 |
| 00815871020244 - Compact Plus | 2020-03-02 |
| 00815871020251 - Compact Plus | 2020-03-02 |